Neomycin and Polymyxin B Sulfates and Hydrocortisone

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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, four drops of the solution should be instilled into the affected ear 3 or 4 times daily.
• For infants and children, three 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 solution.
• This wick should be kept moist by adding further solution every 4 hours.
• The wick should be replaced at least once every 24 hours.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

• The safety and effectiveness of neomycin and polymyxin B sulfates and hydrocortisone otic solution in otitis externa have been established in the pediatric age group 2 years to 16 years of age.
• There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age. 1

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of neomycin and polymyxin B sulfates and hydrocortisone otic solution 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. 2 In another study, the incidence was found to be approximately 1%. 3 Skin hyperpigmentation has been reported with polymyxin B containing products.
• 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 when this product 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Avoid contaminating bottle tip with material from the ear, fingers or other source.
• This caution is necessary if the sterility of the drops is to be preserved.
• If sensitization or irritation occurs, discontinue use immediately and contact your physician.
• Do not use in the eyes.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

• Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is supplied in a white plastic dropper bottle in the following size:
• 10 mL - NDC 85766-249-10 (relabeled from NDC 24208-631-10) Storage:
• Store between 15°C to 25°C (59°F to 77°F).
• Securely tighten cap between uses.
• Keep out of reach of children.
• DoNotUSe

Quoted from the official label, section “How Supplied”.

What is in it

• Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is a sterile antibacterial and anti-inflammatory solution 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:
• propylene glycol, hydrochloric acid, potassium metabisulfite, cupric sulfate, glycerin, purified water.
• The pH range is 2.0 to 4.5.
• 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:
• Schematic Description automatically generated with medium confidence Diagram Description automatically generated Diagram Description automatically generated

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

22 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone