Efinaconazole topical is used to treat a fungal infection of the toenail called onychomycosis.

Efinaconazole 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.

Efinaconazole 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 while using efinaconazole topical.

Use efinaconazole topical 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.

After you apply efinaconazole topical, wait at least 10 minutes before you take a bath or shower.

Store in an upright position at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use. Do not freeze.

Efinaconazole 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 integrated flow-through brush applicator should be used.
-The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

Use: For the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and 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 integrated flow-through brush applicator should be used.
-The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

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

Tell your doctor if you are pregnant or breastfeeding.

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

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

An overdose of efinaconazole 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it upright at room temperature and away from open flames, excess heat and moisture (not in the bathroom). Do not allow the medication to freeze.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not get efinaconazole topical in your eyes, mouth, or vagina. Efinaconazole topical is for use only on the toenails.

Avoid having a pedicure or using nail polish on your toenails.

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

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

• severe redness, itching, or swelling of the affected toenail.

Common side effects of efinaconazole topical may include:

• pain, redness, swelling, burning, stinging, itching, or blisters where the medicine was applied; 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.