21 C.F.R. § 524.1044f Gentamicin sulfate, betamethasone valerate topical spray.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram (mg) gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone. (b) Sponsors. See Nos. 000061 and 054925 in §510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days. (2) Indications for use. For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin. (3) 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
§ 524.1044f Gentamicin sulfate, betamethasone valerate topical spray.
