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(efinaconazole) Topical Solution, 10%
Important information: JUBLIA is for use ontoenails 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 s hould I tell my healthcare provider before us ing 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-thecounter medicines, vitamins, and herbal supplements.
How s hould I us e JUBLIA?
See the “Ins tructions for Us e” at the end of this Patient Information leaflet for detailed information about the right way to us e 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 s hould I avoid while us ing JUBLIA?
- JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
What are the pos s ible s ide 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.
How s hould I s tore 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 s afe and effective us e 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
(efinaconazole) topical solution, 10%
Important information: JUBLIA is for use ontoenails 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).
Step 2: Hold the bottle upside down directly over the affected toenail and allow the product to moisten the brush. By turning the bottle upside down, the entire brush will become wet with the drug solution. Apply one drop of JUBLIA onto the toenail. Do not squeeze the bottle or press/rub the brush firmly against the toenail while applying JUBLIA (See Figure B).
Step 3: For the big toenail, also apply a second drop to the end of the toenail by touching the tip of the moist brush to the end of the toenail (See Figure C). If needed, repeat step 2 to re-wet brush.
Step 4: Use the brush attached to the bottle to gently apply JUBLIA. The goal is to make sure that the entire toenail including the cuticle, folds of the skin next to the sides of the toenail, and underneath the nail are covered with the drug solution. (See Figure D). Pressing or rubbing firmly against the toenail while applying JUBLIA could cause brush deformation and over application of the drug solution.
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.
Last reviewed on RxList: 7/21/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Jublia Information
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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