21 C.F.R. § 524.1044d

Current through September 30, 2024
Section 524.1044d - Gentamicin and betamethasone ointment
(a)Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Amount -
(i)Otitis externa. Instill 3 to 8 drops into the ear canal twice daily for 7 days.
(ii)Infected superficial lesions. Apply to cover the treatment area twice daily for 7 to 14 days.
(2)Indications for use. For the treatment of acute and chronic otitis externa and 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.

21 C.F.R. §524.1044d

47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 10969, Feb. 27, 2014