Title 21

SECTION 524.1044h

524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.

§ 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-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 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.

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005; 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 29, 2016]

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