- (a) Specifications. Each milliliter of suspension contains 23 milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 mg prednisolone acetate.
- (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
- (c) Conditions of use in dogs—(1) Amount. Instill five drops in the ear canal twice daily for 7 consecutive days.
- (2) Indications for use. For the treatment of canine otitis externa 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.
[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48703, July 26, 2016]