21 CFR 524.1044b
§ 524.1044b Gentamicin and betamethasone otic solution.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1044b, § 524.1044b Gentamicin and betamethasone otic solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87603
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Full text
(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 No. 000061 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.