- (a) Sponsor. See No. 000061 in § 510.600(c) of this chapter
- (b) Specifications. A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.
(c) Conditions of use—This product should be administered by a veterinary professional.
- (1) Amount. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.
- (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) in dogs.
- (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[90 FR 40970, Aug. 22, 2025]