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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 April 1 2018.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[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

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]

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