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Code of Federal Regulations Title 21. Food and Drugs § 21.524.1484f Neomycin, prednisolone, and tetracaine otic suspension

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Specifications. The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—

(1) Amount. Instill 2 to 6 drops in the external ear canal 2 or 3 times daily.

(2) Indications for use. For the treatment of acute otitis externa and, to a lesser degree, chronic otitis externa;  as treatment or adjunctive therapy of certain ear conditions caused by or associated with neomycin-susceptible organisms and/or allergy.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.524.1484f Neomycin, prednisolone, and tetracaine otic suspension - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-1484f/

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