21 CFR 524.1144j

§ 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 524.1144j, § 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87613
Permanent ID: ys:prov:87613@1
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Full text

(a) Sponsor. See No. 000061 in § 510.600(c) of this chapter (b) Specifications. A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate. (c) Conditions of use—This product should be administered by a veterinary professional. (1) Amount. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration. (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) 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.