Jublia: Uses, Side Effects and Dosage

What JUBLIA is used for:

• JUBLIA is used to treat an infection on the toenail that does not include the base of the nail caused by certain fungi. It is used in patients who have a healthy immune system.

How JUBLIA works:

JUBLIA stops the fungus from making and maintaining their cell membrane. The membrane becomes weak, the fungus can’t survive, and the infection goes away. JUBLIA starts working after the application, but because toenails grow slowly, you may see improvement over time, with clearer, healthier nail growth.

The ingredients in JUBLIA are:

Medicinal ingredient: Efinaconazole

Non-medicinal ingredients: Alcohol, Butylated Hydroxytoluene, C12-15 Alkyl Lactate, Citric Acid, Cyclomethicone, Diisopropyl Adipate, Disodium Edetate, and Purified Water.

JUBLIA comes in the following dosage form(s):

Solution: 10% w/w of efinaconazole.

Do not use JUBLIA if:

• You are allergic to efinaconazole or to any of the ingredients in JUBLIA.
• You are allergic to any part of the container.

JUBLIA is not approved for use in children.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JUBLIA. Talk about any health conditions or problems you may have, including if you:

• have any other toenail infection.
• have an infection that reach the base of the nail or one that’s only on the side of the toenail.
• have severe athlete’s foot.
• are taking other antifungal medicines.

• are pregnant or plan to become pregnant. It is not known if JUBLIA will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if JUBLIA passes into your breast milk.
• have an HIV infection.
• have diabetes that is not controlled.
• have a supressed immune system (for example, you can get infections easily).

Other warnings you should know about:

• JUBLIA is not to be used in the eyes.

• Store JUBLIA away from all eye products.
• JUBLIA is not to be used inside the vagina.
• Avoid contact of JUBLIA with your eyes, mouth, nose, lips, or open wounds.
• JUBLIA is for use on toenails and skin right beside the toenail only.
• In case of accidental contact rinse thoroughly with water and consult with your healthcare professional.
• JUBLIA is flammable. You must keep it away from heat and flame.
• Avoid the use of toenail polish, cosmetic toenail products, or having non-healthcare professional provided pedicures while using JUBLIA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to use JUBLIA:

• Use JUBLIA exactly as your healthcare professional tells you to.
• JUBLIA is for use on toenails only.
• Use JUBLIA only on the affected toenail(s) as directed by your healthcare professional.
• It is best to apply JUBLIA at bedtime.
• Apply it with the brush applicator that is built into the bottle. Be sure to completely cover the toenail, around the cuticle, the folds of the skin next to the sides of the toenail, and underneath the end of the toenail.
• To help clear up your infection completely, keep using JUBLIA for the prescribed treatment period as given to you by your healthcare professional. Keep using it for this entire period even if your symptoms begin to clear up. Stopping JUBLIA too soon may cause the infection to restart.
• A QR link to a video is located inside the top flap of the box to show how to apply JUBLIA.
• Apply JUBLIA to toenails that are clean and dry. If you shower, bath or wash your feet before applying JUBLIA, wait at least 10 minutes for your feet and toenails to dry before applying.
• Let JUBLIA dry before covering the treated toenail(s) with bedding, socks or other clothing.
• You do not need to remove dead, damaged or infected areas of your toenail(s) before applying JUBLIA.

Usual dose:

Apply JUBLIA once daily to clean, dry toenail(s) using the built-in brush. If you are treating your big toenail(s) you must apply JUBLIA twice (two coats) to each toenail. All other toes require only one application.

TOENAIL

Clip your toenails every four weeks and always discard the clippings. Be sure to clip uninfected toenails before clipping infected toenails. To avoid spreading the infection, do not share toenail clippers. Be sure to clean the toenail clippers after each use. Daily clipping of the toenails is not needed.

Apply JUBLIA as follows:

Step 1: Remove the cap from the JUBLIA bottle.
Step 2: Before the FIRST APPLICATION on DAY 1: Hold the bottle upside down directly over the affected toenail and gently squeeze the bottle to wet the brush. The entire brush will become moistened with the solution.
	Step 3: For all applications: a) Hold the bottle upside down and with the moistened brush attached to the bottle, apply JUBLIA by brushing it gently onto the affected toenail(s). The bottle may be gently squeezed to re-wet the brush if needed. b) Gently spread the solution around the cuticle, folds of the skin next to the sides of the toenail, and underneath the end of the toenail.
Step 4: For the big toenail, repeat the JUBLIA application a second time. Gently brush the solution around the cuticle, nail folds of the skin next to the sides of the toenail, and on the end of the toenail and surrounding skin. Do not squeeze the bottle while spreading the solution. Do not press or rub the brush firmly against the toenail.
Step 5: After applying JUBLIA, the entire toenail and surrounding skin should briefly glisten with a layer of the solution. Let the treated area dry before covering it with bedding, socks or other clothing.
Step 6: Replace the cap tightly on the bottle when finished and store upright.
Step 7: Wash your hands with soap and water after applying JUBLIA.

Overdose:

If you think you, or a person you are caring for, have taken too much JUBLIA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

Try not to miss any doses. If you miss a dose of JUBLIA, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and resume the normal dosing schedule of once a day. Do not double the doses and never make up for the missed dose.

Possible side effects from using JUBLIA:

These are not all the possible side effects you may have when taking JUBLIA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• skin irritation around the toenail such as redness, itching, burning, or stinging.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at controlled room temperature (15-30°C).

Store in an upright position.

Keep away from heat or open flame.

Keep the bottle tightly closed when not in use.

Keep out of reach and sight of children.

If you want more information about JUBLIA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.bauschhealth.ca; or by calling 1-800-361-4261.
• For more information on how to use JUBLIA, please consult www.jublia.ca.

Bausch Health, Canada Inc.

2150 St-Elzear Blvd., West

Laval, Quebec, H7L 4A8

www.bauschhealth.ca

Date of Authorization: 2026-03-06