21 CFR 524.1312
§ 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1312, § 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87622
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.