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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter EPart 524 → §524.1044h

Title 21: Food and Drugs

§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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