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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 Jul 20, 2022.

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: 21CFR524.957]



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. 524.957 Florfenicol, terbinafine, and mometasone otic solution.

(a) Specifications. Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer one dropperette (1 mL) per affected ear(s).

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

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

[80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018; 86 FR 14821, Mar. 19, 2021]

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