Florfenicol, terbinafine and mometasone

Indications

CLARO is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Dosage and Administration

CLARO should be administered by veterinary personnel. Wear eye protection when administering CLARO. (see Human Warnings , Precautions , Post-Approval Experience ). Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure. Shake before use. Verify the tympanic membrane is intact prior to administration. (see Contraindications , Precautions , Post-Approval Experience ). Administer one dose (1 dropperette) per affected ear. 1. Clean and dry the external ear canal before administering the product. 2. Verify the tympanic membrane is intact prior to administration. 3. Remove single dose dropperette from the package. 4. While holding the dropperette in an upright position, remove the cap from the dropperette. 5. Turn the cap over and push the other end of the cap onto the tip of the dropperette. 6. Twist the cap to break the seal and then remove cap from the dropperette. 7. Screw the applicator nozzle onto the dropperette. 8. Insert the tapered tip of the dropperette into the affected external ear canal and squeeze to instill the entire contents (1 mL) into the affected ear. 9. Gently massage the base of the ear to allow distribution of the solution. Restrain the dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs (see Post-Approval Experience ). 10. Repeat with other ear as prescribed. 11. The duration of the effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness. Figure - Wear Eye Protection Figure - Screw the applicator nozzle onto the dropperette. Figure - Gently massage the base of the ear to allow distribution of the solution.

Contraindications

Do not use in dogs with known tympanic membrane perforation (see

Warnings

Human Warnings: CLARO may cause eye injury and irritation (see Precautions , Post-Approval Experience ). If contact with eyes occurs, flush copiously with water for at least 15 minutes. If irritation persists, contact a physician. Humans with known hypersensitivity to any of the active ingredients in CLARO should not handle this product. Not for use in humans. Keep this and all drugs out of the reach of children. Avoid skin contact. In case of accidental ingestion by humans, contact a physician immediately.

Precautions

). CLARO is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

Adverse Reactions

In a field study conducted in the United States (see

Description

CLARO contains 16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate. Inactive ingredients include purified water, propylene carbonate, propylene glycol, ethyl alcohol, and polyethylene glycol.

Information for Owners

Owners should be aware that adverse reactions may occur following administration of CLARO and should be instructed to observe the dog for signs such as ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see Post-Approval Experience ). Owners should be advised to contact their veterinarian if any of the above signs are observed. Owners should also be informed that splatter may occur if the dog shakes its head following administration of CLARO which may lead to ocular exposure. Eye injuries, including corneal ulcers, have been reported in humans and dogs associated with head shaking and splatter following administration. Owners should be careful to avoid ocular exposure (see Precautions , Post-Approval Experience ). PHARMACOLOGY: CLARO Otic Solution is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Mometasone furoate is a glucocorticosteroid with anti-inflammatory activity. MICROBIOLOGY: The compatibility and additive effect of each of the components in CLARO solution was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa in dogs enrolled in the clinical effectiveness study determined that florfenicol and terbinafine hydrochloride inhibit the growth of bacteria and yeast commonly associated with otitis externa in dogs. No consistent synergistic or antagonistic effect of the two antimicrobials was demonstrated. The addition of mometasone furoate to the combination did not impair antimicrobial activity to any clinically significant extent. In a field study (see

Storage

Store between 20°C – 25°C (68°F – 77°F), excursions are permitted 15°C – 30°C (59°F – 86°F).

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• SIMPLERA ® (florfenicol, terbinafine, mometasone furoate), MWI Veterinary Supply Co, dba MWI Animal Health. Set id 1d373a90-890d-4420-af40-262afc5dbf7b.
• SIMPLERA™ (florfenicol, terbinafine, mometasone furoate), Vetoquinol USA, Inc.. Set id 3faf5a84-f5e4-4272-bfad-102d7ac657a4.
• Klentz™ (florfenicol, terbinafine, mometasone furoate), Aurora Pharmaceutical, Inc. Set id ab95013e-ef3a-4290-b673-4107d1a4370e.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming florfenicol and terbinafine and mometasone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.