Cortisporin Tc

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 days (See WARNINGS ).
• The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
• When using the calibrated dropper:
• For
• adults, 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily.
• For pediatric patients, 4 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 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

• See DOSAGE AND ADMINISTRATION .
• The safety and effectiveness of Cortisporin ® TC Otic in infants below one year of age have not been established.
• The efficacy of Cortisporin ® TC Otic in pediatric patients one year or older in the treatment of superficial bacterial infections of the external auditory canal and for the treatment of infections of mastoidectomy and fenestration cavities has been demonstrated in a controlled clinical trial.

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

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

Side effects

• Neomycin occasionally causes skin sensitization.
• Ototoxicity (see WARNINGS section) and nephrotoxicity have also been reported.
• Adverse reactions have occurred with topical use of antibiotic combinations.
• 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.
• In another study the incidence was found to be approximately 1%.
• The following local adverse events 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.
• For medical advice about adverse reactions contact your medical professional.
• To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 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 dropper 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.
• If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to
• avoid loss of potency.
• SHAKE WELL BEFORE USING.

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

What it looks like and how it is packed

• Cortisporin ® TC Otic is supplied as:
• NDC 63481-529-10 10 mL bottle with dropper Each mL contains:
• Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10 mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate.
• Thimerosal (mercury derivative) 0.002% is added as a preservative.
• A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package.
• Shake well before using.
• Store at 20° to 25°C (68° to 77°F).
• Rx only.

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

How to store it

Store at 20° to 25°C (68° to 77°F). Rx only.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Cortisporin ® TC Otic with Neomycin and Hydrocortisone (colistin sulfate—neomycin sulfate—thonzonium bromide—hydrocortisone acetate otic suspension) is a sterile antibacterial and anti-inflammatory aqueous suspension containing in each mL:
• Colistin base activity, 3 mg (as the sulfate);
• Neomycin base activity, 3.3 mg (as the sulfate);
• Hydrocortisone acetate, 10 mg (1%);
• Thonzonium bromide, 0.5 mg (0.05%);
• Polysorbate 80, acetic acid, and sodium acetate in a buffered aqueous vehicle.
• Thimerosal (mercury derivative), 0.002%, is added as a preservative.
• It is a nonviscous liquid, buffered at pH 5, for instillation into the canal of the external ear or direct application to the affected aural skin.
• The structural formulas of colistin sulfate (mixture of Colistin A & B), neomycin sulfate (mixture of neomycin A, B & C), hydrocortisone acetate ((11β)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are represented below:
• Thonzonium Bromide Colistin sulfate Neomycin A Neomycin B Sulfate Hydrocortisone Acetate Neomycin C Sulfate Thonzonium Bromide Colistin Sulfate Neomycin A Neomycin B Sulfate Hydrocortisone Acetate Neomycin C Sulfate

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.

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).

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