Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL Suspension/ Drops — NDC 24208-0635-62 package photo

Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL Suspension/ Drops

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) / 10 mL in 1 BOTTLE, DROPPER
NDC 24208-0635-62
🏷️ FDA NDC (as labeled) 24208-635-62 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 24208-635-62
Product NDC 24208-635
11-digit billing NDC 24208063562
NCPDP billing unit ML — per mL (volume)
RxCUI 310687
UNII WI4X0X7BPJ, 057Y626693, 19371312D4
Application # ANDA064065
SPL Set ID b0ee85dd-5fe1-46a3-9bff-606e489d20b1
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-08-28
Route AURICULAR (OTIC)
Dosage form SUSPENSION/ DROPS
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
GPI-14 87991003101807
GPI class Neomycin-Polymyxin-HC
GCN Seq No 048559
GCN 14025
HICL code 003368
Ingredient (HICL) Neomycin/Polymyxin B/Hydrocort
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8W
Therapeutic class — specific (HIC3) Ear Preparations,Antibiotics
AHFS code 08:12.28.28
AHFS class Polymyxin Antibiotics
FDB label name NEOMYCIN-POLYMYXIN-HC EAR SUSP
FDB brand name Neomycin-Polymyxin-Hc
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 24208-635-62 — 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 → 24208-0635-62. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor Agonists
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.

🏭 Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064065 (ANDA)
Labeler code24208
First marketedAug 1996
Product typeHuman Prescription Drug
Portfolio92 products on file
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.

🩺 Clinical

Label name NEOMYCIN-POLYMYXIN-HC EAR SUSP Ingredient Neomycin/Polymyxin B/Hydrocort
📖 What it is MedlinePlus · NLM

Neomycin, polymyxin, and hydrocortisone otic combination is used to treat outer ear infections caused by certain bacteria. It is also used to treat outer ear infections that can occur after certain types of ear surgery. Neomycin and polymyxin are in a class of medications called antibiotics. They work by stopping the growth of bacteria. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the ear to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
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.

🧪 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.

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

  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • UNII 2225PI3MOV
    A mercury-containing preservative used to prevent bacterial and fungal contamination in multi-dose vials of vaccines and some injectable medicines. It stops microorganisms from growing in the product during storage and use.
  • 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.

6 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.

💲 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 $3.833 $38.33 / 10 ml
Medicaid paysCMS SDUD · 12 mo $5.28 $52.78 / 10 ml
Medicare drug plans payPart D · Q2 2026 $5.70 $56.96 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $6.334 $3.774
▼ Down 37% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mLthis 24208-0635-62 Bausch 1 bottle $3.833 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 61314-0645-11 Sandoz 10 ml $3.833 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 64980-0448-01 Rising 1 bottle $3.833 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 50090-0431-00 A-S 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 50090-2365-00 A-S 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 50090-6336-00 A-S 1 bottle — AT FDA listed —
Neomycin And Polymyxin B Sulfates And Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 60219-2084-06 Amneal 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 63187-0308-10 Proficient 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 63187-0648-10 Proficient 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 63629-8844-01 Bryant 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 68071-4229-01 NuCare 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 68788-7787-01 Preferred 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 68788-8130-01 Preferred 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 68788-9924-01 Preferred 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
1996
On the market since
Aug 1996
📍
2026
Currently FDA-listed
30 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ 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 24208-0635-62, 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 – Q4 2025 · 4 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
112.1K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$5.95M
Avg / prescription
$53.04
Avg / unit
$5.2777
Latest quarter Q4 2025
19.8KRx
Medicaid pays / mL
$5.2777
gross reimbursed
vs
NADAC / mL
$3.8331
acquisition cost
=
Spread
+$1.4446
+38% 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 ⓘ
38% FFS 62% MCO
Fee-for-service · 42,636 Rx Managed care · 69,484 Rx
State Medicaid map
Alaska: 2,360 units · 322 per 100k residents AK Maine: 4,660 units · 334 per 100k residents ME Washington: 18,560 units · 238 per 100k residents WA Idaho: 2,340 units · 119 per 100k residents ID Montana: 2,239 units · 198 per 100k residents MT North Dakota: 1,230 units · 157 per 100k residents ND Minnesota: 10,107 units · 176 per 100k residents MN Wisconsin: 13,180 units · 223 per 100k residents WI Michigan: 24,960 units · 249 per 100k residents MI New York: 101,300 units · 518 per 100k residents NY Vermont: 3,461 units · 535 per 100k residents VT New Hampshire: 1,920 units · 137 per 100k residents NH Oregon: 14,325 units · 338 per 100k residents OR Nevada: 11,210 units · 351 per 100k residents NV Wyoming: 290 units · 49.7 per 100k residents WY South Dakota: 1,076 units · 117 per 100k residents SD Iowa: 12,950 units · 404 per 100k residents IA Illinois: 18,930 units · 151 per 100k residents IL Indiana: 25,344 units · 369 per 100k residents IN Ohio: 47,670 units · 404 per 100k residents OH Pennsylvania: 52,770 units · 407 per 100k residents PA New Jersey: 29,675 units · 319 per 100k residents NJ Massachusetts: 31,904 units · 456 per 100k residents MA California: 190,030 units · 488 per 100k residents CA Utah: 1,820 units · 53.3 per 100k residents UT Colorado: 5,200 units · 88.5 per 100k residents CO Nebraska: 2,500 units · 126 per 100k residents NE Missouri: 14,880 units · 240 per 100k residents MO Kentucky: 26,031 units · 575 per 100k residents KY West Virginia: 8,680 units · 490 per 100k residents WV Virginia: 28,185 units · 323 per 100k residents VA Maryland: 37,608 units · 609 per 100k residents MD Connecticut: 12,660 units · 350 per 100k residents CT Rhode Island: 8,800 units · 804 per 100k residents RI Arizona: 16,150 units · 217 per 100k residents AZ New Mexico: 8,639 units · 409 per 100k residents NM Kansas: 290 units · 9.9 per 100k residents KS Arkansas: 8,510 units · 277 per 100k residents AR Tennessee: 12,899 units · 181 per 100k residents TN North Carolina: 30,655 units · 283 per 100k residents NC South Carolina: 20,668 units · 385 per 100k residents SC Delaware: 1,660 units · 161 per 100k residents DE Oklahoma: 640 units · 15.8 per 100k residents OK Louisiana: 20,040 units · 438 per 100k residents LA Mississippi: 13,196 units · 449 per 100k residents MS Alabama: 13,528 units · 265 per 100k residents AL Georgia: 44,510 units · 404 per 100k residents GA D.C.: 1,955 units · 288 per 100k residents DC Hawaii: 7,350 units · 512 per 100k residents HI Texas: 61,899 units · 203 per 100k residents TX Florida: 66,440 units · 294 per 100k residents FL
Units reimbursed · per 100k residents
9.9804
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 Rhode Island 804 /100k
2 Maryland 609 /100k
3 Kentucky 575 /100k
4 Vermont 535 /100k
5 New York 518 /100k
6 Hawaii 512 /100k
7 West Virginia 490 /100k
8 California 488 /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.

🔬 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 Neomycin and Polymyxin B Sulfates and Hydrocortisone (this brand).

Top reported reactions

Ear Discomfort35
Eye Irritation32
Pain21
Incorrect Route Of Drug Administration19
Ear Pain17
Eye Pain17
Hypoacusis16

Reporter sex

0 reports

Serious outcomes

Hospitalization17
Disabling13
Death3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
24208-0635-62 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 43 words ▾

INDICATIONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

⏱️ Dosage and Administration 153 words ▾

DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 drops of the suspension should be instilled into the affected ear 3 to 4 times daily.

For children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal.

Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours.

The wick should be replaced at least once every 24 hours. SHAKE WELL BEFORE USING.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

⚠️ Warnings 216 words ▾

WARNINGS Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days (see PRECAUTIONS-General ).

Patients being treated with eardrops containing neomycin should be under close clinical observation. Neomycin and polymyxin B sulfates and hydrocortisone otic suspension should not be used in any patient with a perforated tympanic membrane. Discontinue promptly if sensitization or irritation occurs.

Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin.

The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication.

Neomycin containing applications should be avoided for the patient thereafter.

🤒 Adverse Reactions 129 words ▾

ADVERSE REACTIONS Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B.

Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Stinging and burning have been reported rarely when this drug has gained access to the middle ear. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 122 words ▾

CLINICAL PHARMACOLOGY Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. The anti-infective components in the combination are included to provide action against specific organisms susceptible to them.

Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae. The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

📦 How Supplied / Storage and Handling 88 words ▾

HOW SUPPLIED Neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP is supplied in a white plastic dropper bottle in the following size: 10 mL bottle - NDC 24208-635-62 Storage: Store at 15°C to 25°C (59°F to 77°F). FOR USE IN EARS ONLY. KEEP OUT OF REACH OF CHILDREN.

Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2025 Bausch & Lomb Incorporated or its affiliates Revised: March 2025 9115707 (Folded) 9115607 (Flat) DoNotUse

📋 Description 186 words ▾

DESCRIPTION Neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: Actives: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%); Inactives: cetyl alcohol (0.9%), polysorbate 80, propylene glycol, purified water. Sulfuric acid may be added to adjust pH (3.0 - 7.0).

Preservative: thimerosal 0.01%. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae).

It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).

It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: ChemS ChemSt ChemStr

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