Medication-info.com Search Menu

Jublia (Efinaconazole): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
100 mg/mL
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - 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.

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” 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.

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 upright position.
  • JUBLIA is flammable. Keep away from heat and flame.

    Keep JUBLIA and all medicines out of 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 healthcare 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.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Patented. See https://patents.ortho-dermatologics.com for US patent information.

JUBLIA is a registered trademark of Bausch Health Companies Inc. or its affiliates.

© 2025 Bausch Health Companies Inc. or its affiliates

For more information, call 1-800-321-4576.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 07/2025 9462906

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 this 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. Wait at least 10 minutes after showering, bathing, or washing before applying JUBLIA.

Step 1: Remove the cap from the JUBLIA bottle.

Step 2: Prepare JUBLIA for application.

  • Hold the JUBLIA bottle upside down directly over the affected toenail and gently squeeze the bottle to moisten the entire brush with the solution.
  1. Step 3: Apply JUBLIA
  2. • While holding the bottle upside down, use the moistened brush to apply JUBLIA by brushing it gently onto the affected toenail(s). Gently squeeze the JUBLIA bottle to moisten the brush if needed.
  3. • Gently spread JUBLIA over the entire toenail around the cuticle, folds of the skin next to the sides of the toenail, and underneath the end of the toenail.
  4. • Do not squeeze bottle while spreading JUBLIA.
  5. Do not press or rub the brush firmly against the toenail.
  1. Step 4: For the big toenail, repeat Step 3 to apply JUBLIA a second time.

Step 5: After applying JUBLIA, the entire toenail and surrounding skin should be covered with the solution. Let the treated area dry completely before covering it with bedding, socks, or other clothing.

Step 6: Replace the cap tightly on the bottle.

  1. Step 7: Wash your hands with soap and water after applying JUBLIA.

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.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Patented. See https://patents.ortho-dermatologics.com for US patent information.

JUBLIA is a registered trademark of Bausch Health Companies Inc. or its affiliates.

© 2025 Bausch Health Companies Inc. or its affiliates

This Instructions for Use has been approved by the US Food and Drug Administration.

Revised: 07/2025 9462906

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 203567 · View the label on DailyMed

Revision date stated in the text: July 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Jublia

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Azole Antifungal
Active ingredient Efinaconazole 100 mg/mL
Dosage form Solution
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) BAUSCH
FDA approval NDA 203567New Drug Application (NDA) Approved June 6, 2014
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/mL – 4 ml in 1 bottle, with applicator / 1 in 1 carton NDC 0187-5400-04
100 mg/mL – 4 ml in 1 bottle, with applicator / 1 in 1 carton NDC 0187-5400-10
100 mg/mL – 8 ml in 1 bottle, with applicator / 1 in 1 carton NDC 0187-5400-08
100 mg/mL – 2 ml in 1 bottle, with applicator / 1 in 1 carton NDC 0187-5400-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.