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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR524.955]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel.

(a) Specifications. Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.

(b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.

(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius ) and yeast (Malassezia pachydermatis ).

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

[80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021]

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