21 C.F.R. § 524.1465   Mupirocin ointment.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.1465   Mupirocin ointment.

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

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs:

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

(ii) Limitations. Apply twice daily. Treatment should not exceed 30 days. Because of potential hazard of nephrotoxicity due to polyethylene glycol content, care should be exercised in treating deep lesions. Safety of use in pregnant or breeding animals has not been determined. Not for ophthalmic use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[53 FR 39085, Oct. 5, 1988, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

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