§524.1610. Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension.
21 C.F.R. § 524.1610
Specifications. Each gram of suspension contains 10 milligrams (mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg mometasone furoate, and 1 mg posaconazole.
Sponsor. See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogs—
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.
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).
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[75 FR 16346, Apr. 1, 2010]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
Amendments
[75 FR 16346, Apr. 1, 2010]