StacksVerified U.S. regulatory reference

21 CFR §524.1144j

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Sponsor. See No. 000061 in § 510.600(c) of this chapter
  2. (b)Specifications. A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.
  3. (c)Conditions of use—This product should be administered by a veterinary professional.
    1. (1)Amount. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.
    2. (2)Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) in dogs.
    3. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.