Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 524  /  Sec. 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.

(a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) of hydrocortisone aceponate, 15.1 mg of miconazole nitrate, and 1,505 micrograms of gentamicin sulfate.

(b) Sponsor. See No.051311 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount. Instill 1.0 mL in the affected ear once daily for 5 days.

(1) Amount. Instill 1.0 mL in the affected ear once daily for 5 days.

(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [76 FR 78150, Dec. 16, 2011]