Spinosad Topical
Spinosad topical suspension is an antiparasitic treatment used to eliminate head lice infestations and scabies infestations in adults and children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Spinosad Topical: Patient Information Guide
A plain-language walkthrough of Spinosad Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Spinosad Topical Suspension is an antiparasitic medicine used to treat two common infestations:
- Head lice infestations — approved for adults and children 6 months of age and older
- Scabies infestations — approved for adults and children 4 years of age and older
⚙️How it works▾
Spinosad targets the nervous system of lice and mites. It causes a burst of uncontrolled nerve firing — essentially overloading the insect's nervous system. After this period of hyperexcitation, the lice or mites become paralyzed and die. Because this mechanism targets insect nerve receptors, it works directly on the parasites rather than being absorbed into your body in meaningful amounts.
💊How it's taken▾
Spinosad Topical Suspension is applied to the skin or scalp — never swallowed or used in the eyes. The number of applications and the area covered differ depending on what you're treating:
- Head lice: Apply to dry scalp and dry hair, leave on for 10 minutes, then rinse with warm water. A second treatment may be used 7 days later only if live lice are still visible.
- Scabies: Apply to the entire body from the neck down to the soles of the feet. Patients with a balding scalp should also apply it to the scalp, hairline, temples, and forehead. Let it absorb and dry for 10 minutes before dressing, and leave it on for at least 6 hours before showering or bathing.
Always follow your prescriber's specific instructions and shake the bottle well before each use.
🤒Side effects — in detail▾
Most people tolerate Spinosad Topical Suspension well. The most commonly reported side effects include:
- Redness at the application site (for head lice treatment)
- Eye redness or irritation (for head lice treatment)
- Application site irritation, including pain and burning (for scabies treatment)
- Dry skin (for scabies treatment)
- Application site dryness or flaking (less common, head lice treatment)
- Hair loss (reported rarely during head lice treatment)
If you accidentally swallow any of the product, or if a young infant shows unusual symptoms after use, seek medical attention right away or call Poison Control at 1-800-222-1222.
⚠️Warnings & precautions▾
- Not for infants under 6 months: Spinosad Topical Suspension contains benzyl alcohol, which can be dangerous for very young infants. It is not approved for babies younger than 6 months due to a higher risk of the ingredient being absorbed through their skin and because their bodies cannot process it as well.
- Benzyl alcohol risk in newborns: In neonates and low-birth-weight infants, high levels of benzyl alcohol (given intravenously in other settings) have caused a life-threatening condition called "gasping syndrome" — marked by breathing problems, nervous system depression, seizures, and in some cases, death. While topical use is a very different scenario, the product is still not recommended in this age group as a precaution.
- External use only: Do not swallow, use in the eyes, or use vaginally. If swallowed, call Poison Control immediately.
- Children must be supervised: Always apply Spinosad Topical Suspension to a child under direct adult supervision.
🔀What it interacts with▾
The FDA label for Spinosad Topical Suspension does not identify specific drug, food, or substance interactions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Infants under 6 months: Do not use — not approved for this age group due to benzyl alcohol safety concerns.
- Children under 4 years for scabies: Safety and effectiveness for scabies have not been established in children under 4.
- Pregnancy: Spinosad is not expected to absorb into the bloodstream through the skin in meaningful amounts, so fetal exposure is not expected — but always let your doctor know you are pregnant before starting any treatment.
- Breastfeeding: Spinosad is not expected to pass to a nursing infant through breast milk. However, wash the breast area with soap and water before nursing to avoid the baby coming into direct contact with the product.
- Older adults: Clinical studies did not include enough patients over 65 to identify age-specific differences. No dose adjustments are noted, but talk to your doctor if you have concerns.
- Eye sensitivity: Avoid getting the product in or near your eyes. If contact occurs, rinse thoroughly with water.
🚑If you take too much▾
There is no specific antidote if Spinosad Topical Suspension is accidentally swallowed. If ingestion occurs, contact Poison Control at 1-800-222-1222 right away for the latest guidance, and seek medical attention immediately.
🔬Pharmacokinetics — how your body processes it▾
Studies in children with head lice found that spinosad was not measurably absorbed into the bloodstream following a single 10-minute topical application — blood levels were below the detectable limit in all subjects tested across different age groups and formulation strengths. Benzyl alcohol, an ingredient in the suspension, was detectable in the blood of some younger children (6 months to 4 years) after application, though not in older children. This suggests that very young children may absorb the benzyl alcohol component more readily, which is part of why the product is not recommended for infants under 6 months.
📦How to store it▾
Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).
📄 Written from Spinosad Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Spinosad Topical
3 supplements and herbal products have documented interactions with Spinosad Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Spinosad Topical — the kind of thing our pharmacy team would talk through with you at the counter.
Do I need to use a nit comb with this treatment? ▾
What else do I need to do around the house when treating head lice or scabies? ▾
What if lice are still there after the first treatment? ▾
Is this safe for my baby or young child? ▾
Can I use this if I'm pregnant or breastfeeding? ▾
What side effects should I watch out for? ▾
Is Spinosad Topical available over the counter? ▾
When was Spinosad Topical first available? ▾
Who makes Spinosad Topical? ▾
💬 Answers drafted from Spinosad Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Spinosad Topical comes
Spinosad Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical suspension
How this form is used
- Treats head lice infestations in adults and children 6 months of age and older
- Treats scabies infestations in adults and children 4 years of age and older
- For head lice: shake the bottle well, apply to dry scalp and dry hair, leave on for 10 minutes, then rinse with warm water; repeat after 7 days only if live lice are still present
- For scabies: shake the bottle well, rub into skin from neck to soles of feet, allow to dry for 10 minutes before dressing, and leave on for at least 6 hours before bathing
- Avoid contact with eyes; if product gets in or near eyes, rinse thoroughly with water
- Apply to a child only under direct adult supervision
📊 Spinosad Topical across the U.S. market
How Spinosad Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Spinosad Topical is used
A general measure of how commonly Spinosad Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Spinosad Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Spinosad Topical prescribed? Of the 1,596 medications we measure, Spinosad Topical ranks #411 by Medicaid prescriptions — more than 74% of them.
Utilization by Spinosad Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
spinosad 9 MG/ML Medicated Shampoo
Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1085816
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Spinosad Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 5 listed Spinosad Topical NDCs with Medicaid activity.
🔍 Compare Spinosad Topical products
A representative set of FDA-listed product records for Spinosad Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical suspension | ||||
| 9 mg/mL | Topical | Allegis Pharmaceuticals, LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 9 mg/mL | Topical | Allegis Pharmaceuticals, LLC | NDA | View NDC → |
| 9 mg/mL | Topical | Cipher Pharmaceuticals Inc. | NDA | View NDC → |
| 9 mg/mL | Topical | Cipher Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 9 mg/mL | Topical | ParaPRO LLC | NDA | View NDC → |
| 9 mg/mL | Topical | ParaPRO LLC | NDA AUTHORIZED GENERIC | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Spinosad Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Spinosad Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Spinosad Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Spinosad Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 299081 2 dose forms · 6 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 899132No current FDA listingClinical drug / strength (SCD) 140 MGRxCUI 899133270 MGRxCUI 899143560 MGRxCUI 899147810 MGRxCUI 8991511620 MGRxCUI 899139 -
Dose form (SCDF) Medicated Shampoo RxCUI 1085815No current FDA listingClinical drug / strength (SCD) 9 MG/MLRxCUI 1085816
Look up RxCUI 299081 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Spinosad Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Spinosad Topical belongs to the Pediculicide class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. ParaPRO LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.