Jublia

What is Jublia?

Jublia is a prescription medicine used to treat fungal infections of the toenails. It is not known if Jublia is safe and effective for use in children under 6 years of age.

Description

JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use. Each gram of JUBLIA contains 100 mg of efinaconazole. Efinaconazole is an azole antifungal with a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol). The structural formula for efinaconazole is represented below:

JUBLIA contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.

What is the most important information I should know about Jublia?

Jublia is for use on toenails and surrounding skin only. Do not use Jublia in your mouth, eyes, or vagina.

What should I tell my healthcare provider before using Jublia?

Before you use Jublia, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if Jublia can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Jublia passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Jublia?

See the “Instructions for Use” that come with Jublia for detailed information about the right way to use Jublia

• Use Jublia exactly as your healthcare provider tells you to use it.
• Apply Jublia to your affected toenails 1 time each day. Wait for at least 10 minutes after showering, bathing, or washing before applying Jublia.
• Jublia is used for 48 weeks.
• It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic nails) will affect how Jublia works.

What should I avoid while using Jublia?

• Jublia is flammable. Avoid heat and flame while applying Jublia to your toenail.

What are the possible side effects of Jublia?

Jublia may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your healthcare provider if you have any side effects that bother you or that do not go away.

These are not all the possible side effects of Jublia.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of Jublia

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Jublia that is written for health professionals. Do not use Jublia for a condition for which it was not prescribed. Do not give Jublia to other people, even if they have the same condition you have. It may harm them.

How should I store Jublia?

• Store Jublia at room temperature, between 68°F to 77°F (20°C to 25°C). Do not freeze Jublia.
• Keep the bottle tightly closed and store in an upright position.
• Jublia is flammable. Keep away from heat and flame.

Keep Jublia and all medicines out of the reach of children.

What are the ingredients in Jublia?

Active ingredients: efinaconazole

Inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.

Label

PRINCIPAL DISPLAY PANEL