StacksVerified U.S. regulatory reference

21 CFR §524.1132

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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).
  2. (b)Sponsor. See No.051311 in § 510.600(c) of this chapter.
  3. (c)Conditions of use in dogs—(1) Amount. Instill 1.0 mL in the affected ear once daily for 5 days.
    1. (2)Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.