GroundRules
21 CFR 524.1312: Marbofloxacin, terbinafine, and dexamethasone otic suspension.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON