21 C.F.R. § 524.1610

Current through May 31, 2024
Section 524.1610 - Orbifloxacin, mometasone furoate monohydrate, and posaconazole suspension
(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.

21 C.F.R. §524.1610

75 FR 16346, Apr. 1, 2010