21 C.F.R. § 524.1044b Gentamicin sulfate, betamethasone valerate otic solution.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1044b Gentamicin sulfate, betamethasone valerate otic solution.
