21 CFR § 524.1445 - Miconazole, polymixin B, and prednisolone suspension.
§ 524.1445 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.