CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1044d]

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

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1044d Gentamicin and betamethasone ointment.

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount - (i) Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.

(ii) Infected superficial lesions. Apply to cover the treatment area twice daily for 7 to 14 days.

(2) Indications for use. For the treatment of acute and chronic otitis externa and infected superficial lesions caused by bacteria sensitive to gentamicin.

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

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014]