§ 524.1610. Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.
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/us/cfr/t21/s§ 524.1610·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Specifications. Each gram of suspension contains 10 milligrams
(mg)orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole.
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 lbs. instill 4 drops once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy should continue for 7 consecutive days.
(2)Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 16346, Apr. 1, 2010]