21 C.F.R. § 524.1044h
Gentamicin, mometasone, and clotrimazole otic suspension
(a) Specifications. Each gram of suspension contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate or mometasone furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.
(b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5 gram (g), 15 g, or 30 g bottles (2 drops from the 215 g bottle) once daily into the ear canal. For dogs weighing 30 lb or more, instill 8 drops from the 7.5 g, 15 g, or 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.
(2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.