"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...
(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.
- 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 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 1- 800-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.
Last reviewed on RxList: 3/24/2015
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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