StacksVerified U.S. regulatory reference

21 CFR §524.1312

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.
  2. (b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
  3. (c)Conditions of use—(1) Amount. Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration.
    1. (2)Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.