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Jublia

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Jublia

PATIENT INFORMATION

JUBLIA
(joo-blee-uh)
(efinaconazole) Topical Solution, 10%

Important information: JUBLIA is for use on toenails and surrounding skin only. Do not use JUBLIA in your mouth, eyes, or vagina.

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 in children.

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” at the end of this Patient Information leaflet 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.

What should I avoid while using JUBLIA?

  • JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
  • Avoid pedicures, use of nail polish, or cosmetic nail products, while using JUBLIA.

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 does 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 1800-FDA-1088.

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.

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.

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.

Instructions for Use

JUBLIA®
(joo-blee-uh)
(efinaconazole) topical solution, 10%

Important information: JUBLIA is for use on toenails and surrounding skin only. Do not use JUBLIA in your mouth, eyes or vagina.

Read the Instructions for Use that comes with JUBLIA before you start using it. Talk to your healthcare provider if you have any questions.

How to apply JUBLIA:

Your toenails should be clean and dry before you apply JUBLIA.

Step 1: Before you apply JUBLIA to your affected toenail, remove the cap from the JUBLIA bottle (See Figure A).

Figure A

Remove the cap - Illustration

Step 2: Hold the bottle directly over the affected toenail and gently squeeze the bottle to apply one drop of JUBLIA onto the toenail (See Figure B).

Figure B

Hold the bottle directly over the affected toenail - Illustration

Step 3: For the big toenail, also apply a second drop to the end of the toenail (See Figure C).

Figure C

Apply a second drop to the end of the toenail -  Illustration

Step 4: Use the brush attached to the bottle to gently spread JUBLIA around the entire toenail including: the cuticle, folds of the skin next to the sides of the toenail, and underneath the nail (See Figure D). Do not squeeze the bottle while spreading JUBLIA with the brush.

Figure D

Gently spread JUBLIA around the entire toenail - Illustration

Step 5: Repeat Steps 2 to 4 to apply JUBLIA to each affected toenail.

Step 6: Let JUBLIA dry completely.

Step 7: After applying JUBLIA to your affected toenails, place the cap on the bottle and screw it on tightly.

Step 8: Wash your hands with soap and water after applying JUBLIA.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/19/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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