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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 Mar 22, 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: 21CFR524.1465]



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. 524.1465 Mupirocin.

(a) Specifications. Each gram of ointment contains 20 milligrams mupirocin.

(b) Sponsors. See Nos. 025463, 051672, and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Apply twice daily. Treatment should not exceed 30 days.

(2) Indications for use. For the topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and S. intermedius.

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

[72 FR 18119, Apr. 11, 2007, as amended at 75 FR 79296, Dec. 20, 2010; 78 FR 52854, Aug. 27, 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, Feb. 24, 2017]

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