Code of Federal Regulations Title 21. Food and Drugs § 21.524.1044h Gentamicin, mometasone, and clotrimazole otic suspension

(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.