Jublia topical solution contains efinaconazole, an antifungal medication that fights infections caused by fungus.

Jublia solution is used to treat a fungal infection of the toenail called onychomycosis.

Jublia solution is a clear, colorless to pale yellow solution supplied in a white plastic bottle with a flow-through brush applicator.

Jublia solution is for external use only and is not for ophthalmic, oral, or intravaginal use. It is for use on toenails and immediately adjacent skin only.

Avoid pedicures, the use of nail polish, and cosmetic nail products while using Jublia.

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.

Before taking this medicine

You should not use Jublia if you are allergic to efinaconazole.

It is not known whether efinaconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether efinaconazole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

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

Use Jublia solution exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Jublia is usually applied to affected toenails once daily for 48 weeks (approximately 11 months).

Before you apply this medicine, wash and thoroughly dry your toenails. Wait at least 10 minutes after showering, bathing, or washing the area before applying Jublia.

Apply this medicine over the entire toenail and under the tip of the nail. Allow the medicine to dry completely before putting on a sock or shoe.

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

Avoid getting this medicine on any other skin besides the cuticles or the skin around your toenail.

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

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses can increase your risk of infection that is resistant to medication.

Store in an upright position at room temperature, away from moisture and heat. Do not freeze.

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.

Jublia solution is flammable. Do not use near high heat or open flame. Do not smoke until the solution 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

You should not use Jublia if you are allergic to efinaconazole.

It is not known whether efinaconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether efinaconazole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Jublia solution 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 Jublia solution 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.

Do not get this medicine in your eyes, mouth, or vagina. Jublia solution 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 to Jublia: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

Common Jublia side effects 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.