- (a) Specifications. Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.
- (b) Sponsor. See No. 043264 in § 510.600(c) of this chapter.
- (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.
- (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.
- (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[90 FR 40970, Aug. 22, 2025]