Regulation Text
(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.
Authority
21 U.S.C. 360b.