Claro^® (florfenicol, terbinafine, mometasone furoate) Otic Solution

Prescribing Information for Veterinary Professionals

Claro^® (florfenicol, terbinafine, mometasone furoate) Otic Solution features the only FDA-approved, veterinarian-administered, single-dose treatment regimen for canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Just one dose per ear, administered by you — no drops for your clients to take home.

• Anti-infectives
• Dermatology
• Ear health

Concerns

• Canine otitis externa

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

WARNINGS: Not for use in humans. Keep this and all drugs out of reach of children. In case of accidental ingestion by humans, contact a physician immediately. In case of accidental skin contact, wash area thoroughly with water. Avoid contact with eyes. Humans with known hypersensitivity to florfenicol, terbinafine hydrochloride or mometasone furoate should not handle this product.

PRECAUTIONS: Do not administer orally. The use of Claro^® in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering the product. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY on label). Use with caution in dogs with impaired hepatic function (see ANIMAL SAFETY on label). The safe use of Claro^® in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated.