Tavaborole topical is used to treat a fungal infection of the toenail called onychomycosis (ON e koe mye KOE sis).

Tavaborole topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. This medicine is for use only on the toenails.

Tavaborole topical is usually applied once daily for 48 weeks (approximately 11 months).

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Tavaborole topical is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your nail.

Usual Adult Dose for Onychomycosis -- Toenail:

Apply to affected toenail(s) once a day for 48 weeks.

Comments:
-The provided dropper should be used.
-This drug should be applied to the entire toenail surface and under the tip of each treated toenail.

Use: For the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum or T mentagrophytes

Usual Pediatric Dose for Onychomycosis -- Toenail:

6 years or older: Apply to affected toenail(s) once a day for 48 weeks.

Comments:
-The provided dropper should be used.
-This drug should be applied to the entire toenail surface and under the tip of each treated toenail.

Use: For the treatment of onychomycosis of the toenail(s) due to T rubrum or T mentagrophytes

Tavaborole is not approved for use by anyone younger than 6 years old.

It is not known whether tavaborole topical will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of tavaborole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid getting tavaborole topical on any other skin besides the cuticles or the skin around your toenail.

Do not get this medicine in your eyes, mouth, or vagina.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tavaborole topical may cause serious side effects. Call your doctor at once if you have:

• severe redness, swelling, or other irritation of the affected toenail.

Common side effects of tavaborole topical may include:

• skin peeling or redness where the medicine was applied;

• itching; or

• ingrown toenail.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.