Mediclarum
Medicine guide

Neomycin and Polymyxin B Sulfates and Hydrocortisone

3.5 mg/mL + 10000 [USP'U]/mL + 10 mg/mL · Suspension

  • Prescription only
  • Aminoglycoside Antibacterial
Made by
Sandoz Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2021-08-31

What it is

Aminoglycoside Antibacterial

Used for
  • 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…
The label’s usual adult dose

Adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily.

Full directions ↓
Do not take it if

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

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
13other products contain Neomycin Sulfate, Polymyxin B Sulfate and Hydrocortisone — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.

From the official label · 2021-08-31 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2021-08-31

Do not take it if

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

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, 4 drops of the suspension should be instilled into the affected ear 3 or 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.

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

Other 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.
  • General As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
  • If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
  • Treatment should not be continued for longer than 10 days.
  • Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections:
  • kanamycin, paromomycin, streptomycin, and possibly gentamicin.
  • Information for Patients
  • Laboratory Tests Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.
  • Pregnancy Teratogenic Effects Pregnancy Category C.
  • Nursing Mothers Hydrocortisone appears in human milk following oral administration of the drug.
  • Pediatric Use The safety and effectiveness of Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension 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 Geriatric Use Clinical studies of Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • General As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
  • If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed.
  • Treatment should not be continued for longer than 10 days.
  • Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections:
  • kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Teratogenic Effects Pregnancy Category C.
  • Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation.
  • There are no adequate and well-controlled studies in pregnant women.
  • Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Hydrocortisone appears in human milk following oral administration of the drug.
  • Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension is used by a nursing woman.

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 Suspension 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 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.

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 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 product has gained access to the middle ear.
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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 the 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.
  • SHAKE WELL BEFORE USING.

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 Suspension, USP is available in a bottle containing 10mL NDC 61314-645-11.
  • Store at 15° to 25°C (59° to 77°F).
  • Also Available:
  • Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP bottle of 10 mL with sterilized dropper.

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

What is in it

  • Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use.
  • Each mL contains:
  • neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%).
  • The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, glacial acetic acid and Water for Injection.
  • 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 formula are:
  • Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) 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 formula are:
  • Hydrocortisone, 11β,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone.
  • Its structural formula is: neomycin polymyxin polymyxin-text hydrocortisone-chemical

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.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (16)

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Every strength and form (1)

Details

Made bySandoz Inc.
Active substanceNeomycin Sulfate, Polymyxin B Sulfate and Hydrocortisone
Used inAntibiotics, antivirals and antifungals taken into the body
Strength3.5 mg/mL + 10000 [USP'U]/mL + 10 mg/mL
FormSuspension
RouteAuricular (otic)
Packs10 mL in 1 BOTTLE, PLASTIC
NDC61314-645

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).

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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.

Neomycin and Polymyxin B Sulfates and Hydrocortisone10 mg/mL + 3.5 mg/mL + 10000 [USP'U]/mLPrescription onlySuspension/ Drops Bausch & Lomb Incorporated · Neomycin Sulfate, Polymyxin B Sulfate and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone10 mg/mL + 3.5 mg/mL + 10000 [USP'U]/mLPrescription onlySuspension/ Drops A-S Medication Solutions · Neomycin Sulfate, Polymyxin B Sulfate and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone3.5 mg/mL + 10000 [USP'U]/mL + 10 mg/mLPrescription onlySuspension A-S Medication Solutions · Neomycin Sulfate, Polymyxin B Sulfate and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone10 mg/mL + 3.5 mg/mL + 10000 [USP'U]/mLPrescription onlySuspension/ Drops Amneal Pharmaceuticals NY LLC · Neomycin Sulfate, Polymyxin B Sulfate and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone3.5 mg/mL + 10000 [USP'U]/mL + 10 mg/mLPrescription onlySuspension Sandoz Inc · Neomycin Sulfate, Polymyxin B Sulfate and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone3.5 mg/mL + 10000 [iU]/mL + 10 mg/mLPrescription onlySolution Sandoz Inc · Neomycin Sulfate, Polymyxin B Sulfate and Hydrocortisone

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