21 C.F.R. § 524.1484k Neomycin sulfate, prednisolone, tetracaine, and squalane topical-otic suspension.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of suspension contains 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base), 2 milligrams prednisolone, 5 milligrams tetracaine, and 0.25 milliliter squalane. (b) Sponsor. See 017030 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 2 to 3 applications daily or as needed. (2) Indications for use. Indicated for use in dogs and cats for treating acute otitis externa and as adjunctive therapy in management of chronic otitis externa. The product may also be used for treating moist dermatitis in dogs. (3) Limitations. Tetracaine and neomycin have the potential to sensitize. If signs of irritation or sensitivity develop, discontinue use. Prolonged use of this product may result in overgrowth of nonsusceptible organisms. If new infections due to bacteria or fungi appear during therapy, appropriate measures should be taken. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [48 FR 5265, Feb. 4, 1983; 48 FR 8055, Feb. 25, 1983]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484k Neomycin sulfate, prednisolone, tetracaine, and squalane topical-otic suspension.
