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Electronic Code of Federal Regulations

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter EPart 524 → §524.957


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§524.957   Florfenicol, terbinafine, and mometasone otic solution.

(a) Specifications. Each single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer one dropperette (1 mL) per affected ear(s).

(2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018]

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