§524.1044g. Gentamicin, betamethasone, and clotrimazole ointment.
21 C.F.R. § 524.1044g
Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.
No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.
No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.
No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
Conditions of use in dogs—
Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.
From 7.5- or 15-g tubes; 10-, 12.5-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.
From 20-, 40-, or 215-g bottles— 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
From 20- or 215-g bottles— 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016; 91 FR 41560, July 7, 2026]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
Amendments
[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 2014; 81 FR 17608, Mar. 30, 2016; 91 FR 41560, July 7, 2026]