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524.1484k—Neomycin sulfate, prednisolone, tetracaine, and squalane topical-otic suspension.
(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.
(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.
Code of Federal Regulations
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