(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 Nos. 017030 and 058198 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; 86 FR 14821, Mar. 19, 2021; 88 FR 14901, Mar. 10, 2023]
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