Section 524.1044g - Gentamicin, betamethasone, and clotrimazole ointment(a)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.(b)Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.(1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.(2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.(3) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.(4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.(c)Conditions of use in dogs -(1)Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.(i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.(ii) 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.(ii) 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.(2)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.(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.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