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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1044b


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


§524.1044b   Gentamicin and betamethasone otic solution.

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base and betamethasone valerate equivalent to 1 mg betamethasone alcohol.

(b) Sponsors. See Nos. 000061 and 054925 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amounts and indications for use—(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.

(ii) For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin in dogs and cats, apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

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

[71 FR 13542, Mar. 16, 2006]

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