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Spinosad 9 mg/mL Suspension — NDC 52246-0570-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Spinosad 9 mg/mL Suspension — NDC 52246-570-04 (Billing 52246-0570-04)

by ParaPRO LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC

This is a package of Spinosad 9 mg/mL Suspension from ParaPRO LLC, marketed since Jan 2024 and currently FDA-listed; retail pharmacies pay about $2.02 per mL (NADAC). It is this product's only package size.

NDC 52246-0570-04
🏷️ FDA NDC (as labeled) 52246-570-04 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 52246-570-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
52246 labeler · 570 product · 04 package
Package marketed since
Jan 29, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0352246570046
Medicaid fills, this package
39,977 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52246-570-04
Product NDC 52246-570
11-digit billing NDC 52246057004
NCPDP billing unit ML — per mL (volume)
RxCUI 1085816
UNII XPA88EAP6V
UPC 0352246570046
Application # NDA022408
SPL Set ID 0d6e2507-3669-441e-b5ba-86087fd2955d
Established class (EPC) Pediculicide
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-29
Route TOPICAL
Dosage form SUSPENSION
Substance SPINOSAD

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90900048001820
GCN Seq No 066988
GCN 29436
HICL code 037349
Ingredient (HICL) Spinosad
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5R
Therapeutic class — specific (HIC3) Topical Antiparasitics
AHFS code 84:04.12.00
AHFS class Scabicides And Pediculicides
FDB label name SPINOSAD 0.9% TOPICAL SUSP
FDB brand name Spinosad
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066988
  • GCN: 29436
  • GPI-14 (Medi-Span): 90900048001820
  • HICL (First Databank): 037349
  • AHFS class code: 84:04.12.00
  • RxCUI (RxNorm): 1085816
Why two NDCs? The FDA registers this code as 52246-570-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52246-0570-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Pediculicide class.

Pharmacologic class Pediculicide
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SPINOSAD 0.9% TOPICAL SUSP Ingredient Spinosad
📖 What it is MedlinePlus · NLM

Spinosad suspension is used to treat head lice (small insects that attach themselves to the scalp) in adults and children 6 months of age and older. It is also used to treat scabies (mites that attach themselves to the skin) in adults and children 4 years of age and older. Spinosad is in a class of medications called pediculicides. It works by killing the lice and mites.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You don't have to, but you can. A fine-tooth or special nit comb can be used after treatment to help remove dead lice and nits (lice eggs) from the hair. It's optional but can be h...
  • Do I need to use a nit comb with this treatment?
  • Treating the infestation on the body is just one part of the plan. For head lice, wash any recently worn clothing, hats, bedding, and towels in hot water or dry-clean them, and was...
  • What else do I need to do around the house when treating head lice or scabies?
📖 Read our full Spinosad Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Spinosad — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Spinosad (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $2.017 $242.03 / 120 ml
Medicaid paysCMS SDUD · 12 mo $1.82 $218.02 / 120 ml
Medicare drug plans payPart D · Q2 2026 $1.70 $203.72 / 120 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $2.026 $1.881
▲ Up 7% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52246-0570-04 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC 2024-01-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Spinosad 9 mg/mL 28595-0570-04 Allegis 1 bottle $2.017 — Availability likely —
Spinosad 9 mg/mLthis 52246-0570-04 ParaPRO 1 bottle $2.017 — Availability likely —
Spinosad 9 mg/mL 84635-0570-04 Cipher 1 bottle $2.017 — Availability likely —
Natroba 9 mg/mL 52246-0929-04 ParaPRO 1 bottle $2.202 — Availability likely +9%
Natroba 9 mg/mL 84635-0929-04 Cipher 1 bottle $2.202 — Availability likely +9%
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
First FDA approval
Jan 2011
📍
2026
Currently FDA-listed
15 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 18, 2011 RLD RS ⏳ ~7.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9895388 — method of use (U-3365)
2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9895388 ↗ Method of use U-3365 Nov 25, 2033
Common questions
Is there a generic version of SPINOSAD 0.9% TOPICAL SUSP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SPINOSAD 0.9% TOPICAL SUSP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color orange
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Spinosad Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII S38J6RZN16
    Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 0OUO26BB88
    A compound derived from stearyl alcohol that acts as an antistatic agent and emulsifier. It reduces static electricity in the powder and helps blend water and oil components together in the formulation.
  • 492 mg / 1 mL UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerParaPRO LLC
Application holderCIPHER PHARMACEUTICALS INC
FDA applicationNDA022408 (NDA AUTHORIZED GENERIC)
Labeler code52246
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from ParaPRO LLC labeler code 52246

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 202 words ▾

1 INDICATIONS AND USAGE Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. ( 1.2 )

1.1Head Lice Infestations Spinosad Topical Suspension is indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. Adjunctive Measures for Head Lice Infestations Spinosad Topical Suspension should be used in the context of an overall lice management program: Wash in hot water or dry-clean all recently worn clothing, hats, used bedding and towels. Wash personal care items such as combs, brushes and hair clips in hot water.

A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

1.2Scabies Infestations Spinosad Topical Suspension is indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. Adjunctive Measures for Scabies Infestations Wash in hot water or dry-clean any bedding, clothing and towels used by anyone having scabies.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Treatment of head lice infestations ( 2.2 ): Shake bottle well Apply a sufficient amount to cover dry scalp, then apply to dry hair Rinse off with warm water after 10 minutes Repeat treatment only if live lice are seen 7 days after first treatment Treatment of scabies infestations ( 2.3 ): Shake bottle well Apply product to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet Patients with balding scalp should also apply product to the scalp, hairline, temples, and forehead Allow to absorb in the skin and dry for 10 minutes before getting dressed Leave on the skin for at least 6 hours before showering or bathing

2.1Important Administration Instructions For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water.

2.2Treatment of Head Lice Infestations Shake bottle well. Apply a sufficient amount of Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair.

Leave on for 10 minutes, then thoroughly rinse off with warm water. Wash hands after use. If live lice are seen 7 days after the first treatment, a second treatment should be applied.

Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult [see Warnings and Precautions (5.1) ].

2.3Treatment of Scabies Infestations Shake bottle well. Apply a sufficient amount of Spinosad Topical Suspension to skin to completely cover the body from the neck to the toes (including the soles of the feet). For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.

Allow to absorb into the skin and dry for 10 minutes before getting dressed. Leave on the skin for at least 6 hours before showering or bathing. Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult .

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Topical suspension: 0.9% w/w; each gram contains 9 mg of spinosad in a viscous, slightly opaque (white soft particles may be visible), light orange-colored suspension in 120 mL bottles. Topical suspension: 0.9% w/w ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 82 words ▾

5 WARNINGS AND PRECAUTIONS Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 )

5.1Benzyl Alcohol Toxicity Spinosad Topical Suspension contains benzyl alcohol and is not approved for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously [See Use in Specific Populations (8.4) ] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ParaPRO LLC at 1-855-628-7622 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Head Lice Infestations Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to Spinosad Topical Suspension, that occurred in at least 1% of subjects.

Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation Signs Spinosad (N=552) Permethrin 1% (N=457) Application site erythema 17 (3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) Application site irritation 5 (1%) 7 (2%) Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin. Scabies Infestations Spinosad Topical Suspension was studied in three randomized, double-blind, vehicle-controlled trials (Trial 1, Trial 2, and Trial 3) in 592 subjects with scabies infestation, of which 165 were ages 4-17 and 427 were adults.

Subjects received a single application of Spinosad Topical Suspension to the skin from the neck to the soles of the feet, which was washed off after a minimum of 6 hours. Table 2 presents adverse reactions related to Spinosad Topical Suspension treatment that occurred in at least 1% of subjects. Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3) Signs Spinosad (N=322) Vehicle (N=270) Application site irritation Application site irritation also includes application site pain and burning sensation.

8 (3%) 0 (0%) Dry skin 6 (2%) 0 (0%)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Spinosad, the active ingredient in Spinosad Topical Suspension, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. Spinosad Topical Suspension contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ].

In animal reproduction studies, no adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of spinosad in animal studies to the systemic exposure that would be expected in humans after topical use of Spinosad Topical Suspension. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk for birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.

Oral doses of 10, 50 and 200 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 200 mg/kg/day.

Oral doses of 2.5, 10, and 50 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 7 – 19) to pregnant female rabbits. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 50 mg/kg/day.

A two-generation dietary reproduction study was conducted in rats. Oral doses of 3, 10, and 100 mg/kg/day spinosad were administered to male and female rats from 10-12 weeks prior to mating and throughout mating, parturition, and lactation. No reproductive/developmental toxicity was noted at doses up to 10 mg/kg/day.

In the presence of maternal toxicity, increased dystocia in parturition, decreased gestation survival, decreased litter size, decreased pup body weight, and decreased neonatal survival occurred at a dose of 100 mg/kg/day.

8.2Lactation Risk Summary Spinosad, the active ingredient in Spinosad Topical Suspension, is not systemically absorbed by the mother following topical application. Therefore, breastfeeding is not expected to result in the exposure of the child to spinosad [see Clinical Pharmacology (12.3) ] . Advise breastfeeding women to remove Spinosad Topical Suspension from the breast with soap and water before breastfeeding to avoid direct infant exposure to Spinosad Topical Suspension.

Spinosad Topical Suspension contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin of breastfeeding women in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of the infant to Spinosad Topical Suspension [ see Clinical Pharmacology (12.3) ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Spinosad Topical Suspension and any potential adverse effects on the breastfed child from Spinosad Topical Suspension, or from the underlying maternal condition.

8.4Pediatric Use Head Lice Infestation The safety and effectiveness of Spinosad Topical Suspension for the topical treatment of head lice infestation have been established in pediatric patients 6 months of age and older [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . Spinosad Topical Suspension is not recommended in pediatric patients below the age of 6 months because of the potential for… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Spinosad, the active ingredient in Spinosad Topical Suspension, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. Spinosad Topical Suspension contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ].

In animal reproduction studies, no adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of spinosad in animal studies to the systemic exposure that would be expected in humans after topical use of Spinosad Topical Suspension. The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk for birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.

Oral doses of 10, 50 and 200 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 200 mg/kg/day.

Oral doses of 2.5, 10, and 50 mg/kg/day spinosad were administered during the period of organogenesis (gestational days 7 – 19) to pregnant female rabbits. No adverse embryofetal effects were noted at any dose. Maternal toxicity occurred at 50 mg/kg/day.

A two-generation dietary reproduction study was conducted in rats. Oral doses of 3, 10, and 100 mg/kg/day spinosad were administered to male and female rats from 10-12 weeks prior to mating and throughout mating, parturition, and lactation. No reproductive/developmental toxicity was noted at doses up to 10 mg/kg/day.

In the presence of maternal toxicity, increased dystocia in parturition, decreased gestation survival, decreased litter size, decreased pup body weight, and decreased neonatal survival occurred at a dose of 100 mg/kg/day.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Head Lice Infestation The safety and effectiveness of Spinosad Topical Suspension for the topical treatment of head lice infestation have been established in pediatric patients 6 months of age and older [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . Spinosad Topical Suspension is not recommended in pediatric patients below the age of 6 months because of the potential for increased systemic absorption due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier.

Spinosad Topical Suspension contains benzyl alcohol. Intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. The "gasping syndrome" (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birthweight infants when administered intravenously.

Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages of benzyl alcohol, may be more likely to develop toxicity [see Warning and Precautions (5.1) ] .

Scabies Infestation The safety and effectiveness of Spinosad Topical Suspension for the topical treatment of scabies infestation have been established in pediatric patients 4 years of age and older. Use of Spinosad Topical Suspension in this age group is supported by Trial 1 and Trial 2 which included 165 pediatric subjects ages 4 to 17 years old with scabies infestation. The safety and efficacy were generally consistent between pediatric and adult patients. [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

The safety and effectiveness of Spinosad Topical Suspension have not been established in pediatric patients less than 4 years of age with scabies infestation.

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use Clinical studies of Spinosad Topical Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 26 words ▾

10 OVERDOSAGE No specific antidotes for spinosad overdosage are known. If oral ingestion occurs, contact Poison Control (1-800-222-1222) for latest recommendations and seek medical attention immediately.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.

12.2Pharmacodynamics The pharmacodynamics of Spinosad Topical Suspension has not been studied.

12.3Pharmacokinetics Head Lice Infestations An open-label, single-center trial was conducted over a period of seven days to determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with head lice infestation. Fourteen (14) subjects, 4 – 15 years of age, with head lice were enrolled into the trial. All subjects applied a single topical (scalp) treatment of spinosad 1.8% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling.

Results demonstrated that spinosad was below the limit of quantitation (3 ng/mL) in all samples. Plasma concentration of benzyl alcohol was not determined in these subjects. An open-label, two-center trial was conducted over a period of 23 days to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with a head lice infestation.

Twenty-six (26) subjects between 6 months to 4 years of age were enrolled into the study per protocol. All subjects applied a single topical (scalp) treatment of spinosad 0.9% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling over a 12 hour period. Plasma spinosad concentrations were below the limit of quantitation (3 ng/mL) in all samples.

Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 8 plasma samples in 6 out of 26 subjects (25%): four out of 12 subjects in the 6 months to <2 years age group and two out of 14 subjects in the 2 to 4 years age group. The highest observed concentration was 2.37 μg/mL. Benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification (1 μg/mL) for all subjects.

Scabies Infestations An open-label multi-center trial was conducted to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with scabies infestation. The PK bioavailability study was completed in 19 pediatrics subjects 5 to 16 years of age. All subjects applied a single topical body treatment of spinosad 0.9% from the neck down to the soles of the feet and allowed treatment to remain on the body for a minimum of 6 hours after which the test article was washed off.

Subjects underwent plasma sampling over a 12-hour period after treatment. Plasma spinosad concentrations were below the limit of quantification (3 ng/mL) in all samples. Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 9 plasma samples in 6 out of 19 subjects (32%): in 3 out of 10 subjects in the 5 to 9 year age group and in 3 out of 9 subjects in the 10 to 16 years age group.

The highest observed concentration was 3.94 μg/mL at 0.5 hours post-treatment but was below limit of quantification at 1 hour post-treatment for one subject in the 10 to 16 years age group. There were two subjects with a benzyl alcohol concentration at 3 hours post-treatment with the highest value of 3.53 μg/mL for one subject in the 5 to 9 years age group. Plasma concentrations were below limit of quantification (1 μg/mL) at 3 hours for all other subjects; no subject had measurable concentrations at the 6 and 12 hour time points.

The mean (SD) C max , T max , and AUC 0-12h values for benzyl alcohol were 2.737 (1.107) μg/mL, 1.42 (1.242) hours, and 19.240 μg∙h/mL, respectively.

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Spinosad Topical Suspension, 0.9% w/w; each gram contains 9 mg of spinosad in a slightly opaque (white soft particles may be visible), light orange-colored, viscous liquid, supplied in 4 oz (120 mL) high density polyethylene (HDPE) bottles. NDC 52246-570-04 Storage and Handling Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).

📦 Storage and Handling 20 words ▾

Storage and Handling Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).

📋 Description 157 words ▾

11 DESCRIPTION Spinosad Topical Suspension is a slightly opaque, light orange-colored, viscous topical suspension. Spinosad Topical Suspension is a pediculicide and scabicide. Spinosad, the active ingredient, is derived from the fermentation of a soil actinomycete bacterium, Saccharopolyspora spinosa .

Spinosad is a mixture of spinosyn A and spinosyn D in a ratio of approximately 5 to 1 (spinosyn A to spinosyn D). Spinosyn A: The chemical name is: 1 H -as-Indaceno[3,2-d]oxacyclododecin-7,a5-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2 H -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-, (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)- Spinosyn D: The chemical name is: 1 H -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-2,3,4-tri-O-methyl-alpha-L-mannopyranosyl)oxy]-13-[[2R,5S,6R)-5-(dimethylamino) tetrahydro-6-methyl-2 H -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aSR,5aS,5bS,9S,13S,14R,16aS,16bS)- Spinosyn A (C 41 H 65 NO 10 ) MW 731.461 Spinosyn D (C 42 H 67 NO 10 ) MW 745.477 Spinosad Topical Suspension contains 9 mg spinosad per gram in a vehicle consisting of Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth-20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Stearalkonium Chloride, Water, Hydrochloric acid (HCl) as pH adjuster.

Chemical Structure Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information) Important Administration Instructions Instruct the patient to: Shake bottle well immediately prior to application. Do not swallow. Avoid contact with eyes.

If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water. Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult. If skin/scalp irritation occurs after use, contact your physician [see Adverse Reactions (6.1) ] .

Head Lice Infestation Treatment Apply Spinosad Topical Suspension only on dry scalp and dry scalp hair. Repeat treatment only if live lice are seen seven (7) days after first treatment. Wash hands after applying Spinosad Topical Suspension.

Scabies Infestation Treatment Apply Spinosad Topical Suspension to completely cover the body from the neck to the toes (including the soles of the feet). For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead. Allow it to absorb in the skin and dry for 10 minutes before getting dressed.

Leave on the skin for at least 6 hours before showering or bathing. Wash your hands after applying Spinosad Topical Suspension to someone else. For breastfeeding women, remove Spinosad Topical Suspension from the breast with soap and water before breastfeeding to avoid direct infant exposure to Spinosad Topical Suspension [see Use in Specific Populations (8.2) ]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Head Lice Infestations An open-label, single-center trial was conducted over a period of seven days to determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with head lice infestation. Fourteen (14) subjects, 4 – 15 years of age, with head lice were enrolled into the trial. All subjects applied a single topical (scalp) treatment of spinosad 1.8% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling.

Results demonstrated that spinosad was below the limit of quantitation (3 ng/mL) in all samples. Plasma concentration of benzyl alcohol was not determined in these subjects. An open-label, two-center trial was conducted over a period of 23 days to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with a head lice infestation.

Twenty-six (26) subjects between 6 months to 4 years of age were enrolled into the study per protocol. All subjects applied a single topical (scalp) treatment of spinosad 0.9% for 10 minutes, after which the test article was washed off, and subjects underwent plasma sampling over a 12 hour period. Plasma spinosad concentrations were below the limit of quantitation (3 ng/mL) in all samples.

Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 8 plasma samples in 6 out of 26 subjects (25%): four out of 12 subjects in the 6 months to <2 years age group and two out of 14 subjects in the 2 to 4 years age group. The highest observed concentration was 2.37 μg/mL. Benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification (1 μg/mL) for all subjects.

Scabies Infestations An open-label multi-center trial was conducted to determine the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric subjects with scabies infestation. The PK bioavailability study was completed in 19 pediatrics subjects 5 to 16 years of age. All subjects applied a single topical body treatment of spinosad 0.9% from the neck down to the soles of the feet and allowed treatment to remain on the body for a minimum of 6 hours after which the test article was washed off.

Subjects underwent plasma sampling over a 12-hour period after treatment. Plasma spinosad concentrations were below the limit of quantification (3 ng/mL) in all samples. Benzyl alcohol was quantifiable (above 1 μg/mL) in a total of 9 plasma samples in 6 out of 19 subjects (32%): in 3 out of 10 subjects in the 5 to 9 year age group and in 3 out of 9 subjects in the 10 to 16 years age group.

The highest observed concentration was 3.94 μg/mL at 0.5 hours post-treatment but was below limit of quantification at 1 hour post-treatment for one subject in the 10 to 16 years age group. There were two subjects with a benzyl alcohol concentration at 3 hours post-treatment with the highest value of 3.53 μg/mL for one subject in the 5 to 9 years age group. Plasma concentrations were below limit of quantification (1 μg/mL) at 3 hours for all other subjects; no subject had measurable concentrations at the 6 and 12 hour time points.

The mean (SD) C max , T max , and AUC 0-12h values for benzyl alcohol were 2.737 (1.107) μg/mL, 1.42 (1.242) hours, and 19.240 μg∙h/mL, respectively.

🧬 Pharmacodynamics 12 words ▾

12.2Pharmacodynamics The pharmacodynamics of Spinosad Topical Suspension has not been studied.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Head Lice Infestations Two multicenter, randomized, investigator-blind, active-controlled trials were conducted in 1038 subjects 6 months of age and older with head lice infestation. A total of 552 subjects were treated with Spinosad Topical Suspension. For the evaluation of efficacy, the youngest subject from each household was considered to be the primary subject of the household, and other members in the household were enrolled in the study as secondary subjects and evaluated for all safety parameters.

In Study 1, 91 primary subjects were randomized to Spinosad Topical Suspension, and 89 primary subjects were randomized to permethrin 1%. In Study 2, 83 and 84 primary subjects were randomized to Spinosad Topical Suspension and permethrin 1%, respectively. In both trials, all subjects who were treated on Day 0 returned for efficacy evaluation at Day 7.

Subjects with live lice present at Day 7 received a second treatment. Subjects who were lice free on Day 7 were to return on Day 14 for evaluation. Subjects with live lice and who received a second treatment were to return on Days 14 and 21.

Efficacy was assessed as the proportion of primary subjects who were free of live lice 14 days after the final treatment. Table 3 contains the proportion of primary subjects who were free of live lice in each of the two trials. Table 3.

Proportion of Subjects Free of Live Lice 14 days After Last Treatment Study 1 Study 2 Spinosad (N=91) Permethrin 1% (N=89) Spinosad (N=83) Permethrin 1% (N=84) 77 (84.6%) 40 (44.9%) 72 (86.7%) 36 (42.9%)

14.2Scabies Infestations Two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 [ NCT02485717 ] and Trial 2 [ NCT02485704 ]) were conducted in subjects from 206 households in which at least one household member 4 years of age or older had an active scabies infestation. An active scabies infestation was defined as the presence of clinical signs and symptoms (evidence of burrows or presence of inflammatory/ noninflammatory lesions and pruritus) as well as microscopic evidence from a skin scraping or dermatoscopy to demonstrate the presence of mites, eggs, and/or scybala.

All members of the household were treated with the same randomized treatment (Spinosad Topical Suspension or vehicle), whether or not the household member had an active scabies infestation. Subjects applied a single application of Spinosad Topical Suspension or vehicle on Day 1 and returned for evaluation on Day 28. The two studies enrolled 533 adult and pediatric subjects 4 years of age and older.

A total of 286 subjects (212 adults and 74 pediatrics) were treated with Spinosad Topical Suspension and 247 subjects (176 adults and 71 pediatrics) were treated with vehicle. For the evaluation of efficacy, the youngest subject from each household with an active scabies infestation was considered to be the primary subject of the household, and other members in the household were enrolled in the trial as secondary subjects and evaluated for all safety parameters. In Trial 1, 43 primary subjects were randomized to Spinosad Topical Suspension, and 43 primary subjects were randomized to vehicle.

In Trial 2, 62 and 58 primary subjects were randomized to Spinosad Topical Suspension and vehicle, respectively. Efficacy was assessed as the proportion of primary subjects who achieved complete cure 28 days after treatment. Complete cure is defined as a demonstration of clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and negative dermatoscopy for burrows.

Table 4 contains the proportion of primary subjects who achieved complete cure in each of the two trials. Table 4. Proportion of Primary Subjects with Scabies Infestation who Achieved Complete Cure 28 Days After Treatment Trial 1 Trial 2 Spinosad N=43 Vehicle N=43 Estimated Differe… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In an oral (diet) mouse carcinogenicity study, spinosad was administered to CD-1 mice at doses of 0.0025, 0.008, and 0.036% in the diet (approximately 3.4, 11.4, and 50.9 mg/kg/day for males and 4.2, 13.8, and 67.0 mg/kg/day for females) for 18 months. No treatment-related tumors were noted in the mouse carcinogenicity study up to the highest doses evaluated in this study of 50.9 mg/kg/day in male mice and 13.8 mg/kg/day in female mice. Female mice treated with a dose of 67.0 mg/kg/day were not evaluated in this study due to high mortality.

In an oral (diet) rat carcinogenicity study, spinosad was administered to Fischer 344 rats at doses of 0.005, 0.02, 0.05, and 0.1% in the diet (approximately 2.4, 9.5, 24.1 and 49.4 mg/kg/day for males and 3.0, 12.0, 30.1 and 62.8 mg/kg/day for females) for 24 months. No treatment-related tumors were noted in the rat carcinogenicity study in male or female rats up to the highest doses evaluated in this study of 24.1 mg/kg/day in male rats and 30.1 mg/kg/day in female rats. Rats in the highest dose group in this study were not evaluated due to high mortality.

Spinosad demonstrated no evidence of mutagenic or clastogenic potential based on the results of four in vitro genotoxicity tests (Ames assay, mouse lymphoma L5178Y assay, Chinese hamster ovary cell chromosome aberration assay, and rat hepatocyte unscheduled DNA synthesis assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay). Oral administration of spinosad (in diet) to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 10 mg/kg/day [see Use In Specific Populations (8.1) ] .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In an oral (diet) mouse carcinogenicity study, spinosad was administered to CD-1 mice at doses of 0.0025, 0.008, and 0.036% in the diet (approximately 3.4, 11.4, and 50.9 mg/kg/day for males and 4.2, 13.8, and 67.0 mg/kg/day for females) for 18 months. No treatment-related tumors were noted in the mouse carcinogenicity study up to the highest doses evaluated in this study of 50.9 mg/kg/day in male mice and 13.8 mg/kg/day in female mice. Female mice treated with a dose of 67.0 mg/kg/day were not evaluated in this study due to high mortality.

In an oral (diet) rat carcinogenicity study, spinosad was administered to Fischer 344 rats at doses of 0.005, 0.02, 0.05, and 0.1% in the diet (approximately 2.4, 9.5, 24.1 and 49.4 mg/kg/day for males and 3.0, 12.0, 30.1 and 62.8 mg/kg/day for females) for 24 months. No treatment-related tumors were noted in the rat carcinogenicity study in male or female rats up to the highest doses evaluated in this study of 24.1 mg/kg/day in male rats and 30.1 mg/kg/day in female rats. Rats in the highest dose group in this study were not evaluated due to high mortality.

Spinosad demonstrated no evidence of mutagenic or clastogenic potential based on the results of four in vitro genotoxicity tests (Ames assay, mouse lymphoma L5178Y assay, Chinese hamster ovary cell chromosome aberration assay, and rat hepatocyte unscheduled DNA synthesis assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay). Oral administration of spinosad (in diet) to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 10 mg/kg/day [see Use In Specific Populations (8.1) ] .

📄 Patient Package Insert ~3 min read ▾

Patient Information for Head Lice Treatment Spinosad Topical Suspension Important: For use on scalp hair and scalp only. Do not get Spinosad Topical Suspension in your eyes, mouth, or vagina. What is Spinosad Topical Suspension?

Spinosad Topical Suspension is a prescription medicine used to treat head lice on the scalp and hair of adults and children 6 months of age and older. It is not known if Spinosad Topical Suspension is safe and effective for children under 6 months of age. See "How do I stop the spread of lice?" at the end of this leaflet for additional information on ways to stop the spread of lice.

Before you use Spinosad Topical Suspension, tell your healthcare provider about all of your medical conditions, including if you or your child: have any skin conditions or sensitivities are pregnant or plan to become pregnant. It is not known if Spinosad Topical Suspension can harm your unborn baby. are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with Spinosad Topical Suspension.

How should I use Spinosad Topical Suspension? See the detailed " Instructions for Use " at the end of this leaflet. Apply Spinosad Topical Suspension exactly as prescribed by your healthcare provider.

Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider. Apply Spinosad Topical Suspension when your hair is dry.

Do not wet your hair before applying Spinosad Topical Suspension. It is important to apply enough Spinosad Topical Suspension to completely coat all of your hair and scalp. Leave Spinosad Topical Suspension on your hair and scalp for a full 10 minutes.

If live lice are seen one week (7 days) after you applied Spinosad Topical Suspension, you will need to apply Spinosad Topical Suspension again. Because you need to completely cover all of the lice with Spinosad Topical Suspension, you may need help in applying Spinosad Topical Suspension to your scalp and hair. Children will need an adult to apply Spinosad Topical Suspension for them.

Do not get Spinosad Topical Suspension into your eyes . If Spinosad Topical Suspension gets in your eye, rinse well with water right away. If you have any scalp irritation after you apply Spinosad Topical Suspension, call your healthcare provider right away.

Wash your hands after you apply Spinosad Topical Suspension. Do not swallow Spinosad Topical Suspension. If swallowed, call Poison Control at 1-800-222-1222 or go to the nearest emergency room right away.

What are the possible side effects of Spinosad Topical Suspension? The most common side effects of Spinosad Topical Suspension include redness where Spinosad Topical Suspension is applied and redness to eyes. These are not all the possible side effects of Spinosad Topical Suspension.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Spinosad Topical Suspension?

Store Spinosad Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C). Keep Spinosad Topical Suspension and all medicines out of the reach of children. General information about the safe and effective use of Spinosad Topical Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Spinosad Topical Suspension for a condition for which it was not prescribed. Do not give Spinosad Topical Suspension to other people, even if they have the same symptoms that you have.

It may harm them. You can ask your pharmacist or healthcare provider for information about Spinosad Topical Suspension that is written for health professionals. What are the ingredients in Spinosad Topical Suspension?

Active ingredient: spinosad Inactive ingredients: Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth-20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopro… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use Before you use Spinosad Topical Suspension, it is important that you read this Instructions for Use. Be sure that you read, understand, and follow this Instructions for Use so that you use Spinosad Topical Suspension the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Spinosad Topical Suspension.

Important information: Your hair and scalp must be dry before applying Spinosad Topical Suspension. For very thick, medium length hair or long hair, an entire bottle (120mL) of Spinosad Topical Suspension may be needed to cover the scalp and hair. Less Spinosad Topical Suspension may be needed for shorter, thinner hair.

How to apply Spinosad Topical Suspension to your scalp and hair: Step 1 Shake Spinosad Topical Suspension bottle well right before use. Step 2 Cover your face and eyes with a towel and keep your eyes closed tightly. Apply Spinosad Topical Suspension directly to dry hair and scalp.

Completely cover the scalp and hair closest to the scalp first, and then apply outwards towards the ends of the hair. It is important to apply enough Spinosad Topical Suspension to cover your entire scalp and hair so that all lice and eggs are exposed to Spinosad Topical Suspension. Step 3 Allow Spinosad Topical Suspension to stay on your scalp and hair for 10 minutes.

Use a timer or clock and start timing after you have completely covered your hair and scalp with Spinosad Topical Suspension. Continue to keep eyes covered to prevent dripping into your eyes. After 10 minutes, completely rinse Spinosad Topical Suspension from your hair and scalp with warm water.

You may use a fine-tooth comb to remove treated lice and nits from the hair and scalp, but combing is not required. Wash your hands after applying Spinosad Topical Suspension. It is okay to shampoo your hair any time after the treatment.

If you see live lice on your scalp or hair one week (7 days), after your first treatment, repeat the steps above. How do I stop the spread of lice? To help prevent the spread of lice from one person to another, here are some steps you can take: Avoid direct head-to-head contact with anyone known to have live, crawling lice.

Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not. Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.

After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice. Machine-wash or dry-clean any bedding, towels and clothing used by anyone having lice.

Machine-wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes. Wash personal items such as combs, brushes, and hair clips in hot water. Distributed by: ParaPRO LLC, Brownsburg, IN 46112 This Patient Information and Instructions for Use have been approved by the U.S.

Food and Drug Administration. Revised: 01/2024 Step 1 Step 2 Step 3

Instructions for Use Before you use Spinosad Topical Suspension, it is important that you read this Instructions for Use. Be sure that you read, understand, and follow this Instructions for Use so that you use Spinosad Topical Suspension the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to use Spinosad Topical Suspension.

How to apply Spinosad Topical Suspension to your body: Step 1 Shake the Spinosad Topical Suspension bottle well right before use. Step 2 Figure A Figure B Figure C Apply Spinosad Topical Suspension to the skin. (See Figure A ) Apply enough Spinosad Topical Suspension to completely cover your body from your neck to the soles of your feet.

(See Figure B ). Make sure you apply to folds of skin, between fingers and toes, and under finge… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 6 words ▾

How Supplied ( 16 ) 01/2024

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 120 mL Carton NDC 52246-570-04 Rx Only Spinosad Topical Suspension 0.9% w/w For topical use only 120 mL DIRECTIONS FOR USE See package insert, including the patient information section, for full prescribing and dosing information. SHAKE WELL BEFORE USE. WARNINGS: Keep out of the reach of children.

Spinosad Topical Suspension should be used on children under direct supervision of an adult. Do not swallow. Avoid contact with eyes.

If Spinosad Topical Suspension gets into the eyes, immediately flush with water. If scalp irritation or infection occurs after use contact a physician. Manufactured for: ParaPRO, LLC, Carmel, IN 46032 Distributed by: ParaPRO, LLC, Brownsburg, IN 46112 ParaPRO is a registered trademark of ParaPRO, LLC.

Spinosad Topical Suspension contains 9 mg spinosad per gram of compound consisting of Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth -20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Stearalkonium Chloride, Water, Hydrochloric acid (HCl) as pH adjuster. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). carton

PRINCIPAL DISPLAY PANEL - 120 mL Bottle NDC 52246-570-04 Rx Only Spinosad Topical Suspension 0.9% w/w For topical use only 120 mL DIRECTIONS FOR USE See package insert, including the patient information section, for full prescribing and dosing information. SHAKE WELL BEFORE USE. WARNINGS: Keep out of the reach of children.

Spinosad Topical Suspension should be used on children under direct supervision of an adult. Do not swallow. Avoid contact with eyes.

If Spinosad Topical Suspension gets into the eyes, immediately flush with water. If scalp irritation or infection occurs after use contact a physician. Manufactured for: ParaPRO, LLC, Carmel, IN 46032 Distributed by: ParaPRO, LLC, Brownsburg, IN 46112 ParaPRO is a registered trademark of ParaPRO, LLC.

Spinosad Topical Suspension contains 9 mg spinosad per gram of compound consisting of Benzyl Alcohol, Butylated Hydroxytoluene, Ceteareth -20, Cetearyl Alcohol, FD&C Yellow #6, Hexylene Glycol, Hydroxyethyl Cellulose, Isopropyl Alcohol, Propylene Glycol, Stearalkonium Chloride, Water, Hydrochloric acid (HCl) as pH adjuster. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). bottle

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
40K
Units reimbursed last 4 qtrs
4.9M
Gross reimbursed last 4 qtrs
$8.92M
Avg / prescription
$223.25
Avg / unit
$1.8168
Latest quarter Q1 2026
15.3KRx
Medicaid pays / mL
$1.8168
gross reimbursed
vs
NADAC / mL
$2.0169
acquisition cost
=
Spread
−$0.2001
-10% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 13,287 Rx Managed care · 26,690 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,160 units · 155 per 100k residents ME Washington: 69,121 units · 885 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 140,870 units · 1,404 per 100k residents MI New York: 531,522 units · 2,716 per 100k residents NY Vermont: 3,960 units · 612 per 100k residents VT New Hampshire: 8,160 units · 582 per 100k residents NH Oregon: 16,320 units · 386 per 100k residents OR Nevada: 17,640 units · 552 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,920 units · 209 per 100k residents SD Iowa: 17,640 units · 550 per 100k residents IA Illinois: 5,640 units · 44.9 per 100k residents IL Indiana: 113,043 units · 1,647 per 100k residents IN Ohio: 102,360 units · 869 per 100k residents OH Pennsylvania: 34,135 units · 263 per 100k residents PA New Jersey: 3,600 units · 38.8 per 100k residents NJ Massachusetts: 2,880 units · 41.1 per 100k residents MA California: 363,117 units · 932 per 100k residents CA Utah: no data reported UT Colorado: 25,800 units · 439 per 100k residents CO Nebraska: no data reported NE Missouri: 4,080 units · 65.8 per 100k residents MO Kentucky: 6,000 units · 133 per 100k residents KY West Virginia: 18,420 units · 1,041 per 100k residents WV Virginia: 53,220 units · 611 per 100k residents VA Maryland: 12,356 units · 200 per 100k residents MD Connecticut: 15,360 units · 425 per 100k residents CT Rhode Island: 19,440 units · 1,775 per 100k residents RI Arizona: 1,800 units · 24.2 per 100k residents AZ New Mexico: no data reported NM Kansas: 140,521 units · 4,780 per 100k residents KS Arkansas: no data reported AR Tennessee: 223,743 units · 3,140 per 100k residents TN North Carolina: 41,640 units · 384 per 100k residents NC South Carolina: 8,580 units · 160 per 100k residents SC Delaware: no data reported DE Oklahoma: 23,414 units · 578 per 100k residents OK Louisiana: 301,920 units · 6,601 per 100k residents LA Mississippi: 32,160 units · 1,094 per 100k residents MS Alabama: 407,290 units · 7,974 per 100k residents AL Georgia: 386,998 units · 3,509 per 100k residents GA D.C.: 2,280 units · 336 per 100k residents DC Hawaii: 24,000 units · 1,672 per 100k residents HI Texas: 901,204 units · 2,954 per 100k residents TX Florida: 828,152 units · 3,663 per 100k residents FL
Units reimbursed · per 100k residents
24.27,974
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alabama 7,974 /100k
2 Louisiana 6,601 /100k
3 Kansas 4,780 /100k
4 Florida 3,663 /100k
5 Georgia 3,509 /100k
6 Tennessee 3,140 /100k
7 Texas 2,954 /100k
8 New York 2,716 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Spinosad — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Spinosad. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$129.5K
Claims incl. refills
548
Beneficiaries
409
Spend / beneficiary
$316.75
Spend / claim
$236.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Spinosad — the ingredient across all brands.

Top reported reactions

Pruritus7
Alopecia5
Rash4
Condition Aggravated3
Erythema3
Abdominal Pain Upper2
Burning Sensation2

Reporter sex

45 reports
Male · 29%
Female · 69%
Unknown · 3%

Serious outcomes

Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 52244-0400-10 · ENDO 52246-0929-04 · ParaPRO →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.