Neomycin and Polymyxin B Sulfates and Hydrocortisone

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

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. 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 To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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.

Information for Patients 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. SHAKE WELL BEFORE USING.

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, equal 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 ADDED: 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 to not less than 600 micrograms of neomycin standard per milligram, 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 milligram, 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: C 21 H 30 O 5 Mol. Wt. 362.46 C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-01.jpg C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-02.jpg C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-03.jpg

HOW SUPPLIED Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is supplied as white to off-white uniform suspension, filled in 10 mL low-density polyethylene white opaque bottle with low-density polyethylene white opaque nozzle and high-density polyethylene white opaque cap. They are available as follow: 10 mL Bottle: NDC 60219-2084-6 Store at 15° to 25°C (59° to 77°F). Rx only KEEP OUT OF THE REACH OF CHILDREN. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2025-00