- (a) Specifications. Each milliliter (mL) of suspension contains 1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
- (b) Sponsor. See No.051311 in § 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.
- (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, as amended at 83 FR 13635, Mar. 30, 2018]