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Code of Federal Regulations Title 21. Food and Drugs § 21.524.1484i Neomycin and hydrocortisone ointment

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

(a) Specifications. The drug contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams of hydrocortisone acetate in each gram of ointment.  1

1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

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

(c) Conditions of use in dogs and cats—

(1) Amount. Apply 3 or 4 times daily into the conjunctival sac. With improvement, frequency may be reduced to 2 or 3 times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal 1 to 3 times daily.

(2) Indications for use. For the treatment of infections, allergic and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa.

(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 § 21.524.1484i Neomycin and hydrocortisone ointment - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-1484i/

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