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Code of Federal Regulations Title 21. Food and Drugs § 21.524.1044b Gentamicin and betamethasone otic solution

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.524.1044b Gentamicin and betamethasone otic solution - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-1044b/

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