21 C.F.R. § 524.1044f

Current through September 30, 2024
Section 524.1044f - Gentamicin and betamethasone spray
(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, 017033, 054925, 058005, and 058829 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 susceptible to gentamicin.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §524.1044f

71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012; 88 FR 16549, Mar. 20, 2023
85 FR 4208, 1/24/2020; 88 FR 16549, 3/20/2023