Miconazole, polymixin B, and prednisolone suspension.

(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]