StacksVerified U.S. regulatory reference

21 CFR §524.2338

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each milliliter of gel contains 10 milligrams (mg) terbinafine and 1 mg betamethasone acetate.
  2. (b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
  3. (c)Conditions of use in dogs—(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
    1. (2)Indications for use. For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.