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

What is tavaborole topical solution?

Tavaborole topical solution is a prescription medicine used to treat fungal infections of the toenails.

It is not known if tavaborole topical solution is safe and effective in children less than 6 years age.

Before using tavaborole topical solution, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if tavaborole topical solution can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if tavaborole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with tavaborole topical solution.

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 tavaborole topical solution?

See the “Instructions for Use” at the end of this Patient Information for detailed information about the right way to use tavaborole topical solution.

Use tavaborole topical solution exactly as your healthcare provider tells you to use it.
Apply tavaborole topical solution to your affected toenails 1 time each day.
Tavaborole topical solution 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 tavaborole topical solution works.

What should I avoid while using tavaborole topical solution?

Tavaborole topical solution is flammable. Avoid heat and flame while applying tavaborole topical solution to your toenail.

What are the possible side effects of tavaborole topical solution?

The most common side effects of tavaborole topical solution include: skin peeling, ingrown toenail, redness, itching, and swelling.

Tavaborole topical solution may cause irritation at or near the application site. Tell your healthcare provider if you develop irritation at the application site that does not go away. These are not all of the possible side effects of tavaborole topical solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store tavaborole topical solution?

Store tavaborole topical solution at room temperature, between 68°F to 77°F (20°C to 25°C).
Tavaborole topical solution is flammable. Keep away from heat and flame.
Keep the bottle tightly closed.
Safely throw away tavaborole topical solution after 3 months of inserting the dropper.

Keep tavaborole topical solution and all medicines out of the reach of children.

General information about the safe and effective use of tavaborole topical solution

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tavaborole topical solution for a condition for which it was not prescribed. Do not give tavaborole topical solution to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about tavaborole topical solution that is written for health professionals.

What are the ingredients in tavaborole topical solution?

Active ingredient: tavaborole

Inactive ingredients: alcohol USP (87.43% v/v), propylene glycol USP, and edetate calcium disodium USP

Manufactured by:

Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate,

Madkaim, Post: Mardol, Ponda, Goa - 403 404,

India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Drive, Suite 202

Durham, NC 27713 USA

For more information, call Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088

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

Rev.07/24

Instructions for Use

Tavaborole (ta va bor ole) topical solution, 5%

Important information: Tavaborole topical solution is for use on toenails only. Do not use tavaborole topical solution in your mouth, eyes, or vagina.

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

How to apply tavaborole topical solution:

Your toenails should be clean and dry before you apply tavaborole topical solution.

Step 1: Before you apply tavaborole topical solution to your affected toenail for the first time, remove the cap from the tavaborole topical solution bottle. (See Figure A) Throw away the cap.

Step 2: Remove the wrapping from the dropper that comes with tavaborole topical solution. insert the dropper into the tavaborole topical solution bottle. (See Figure B)

Figure A Figure B

Only apply tavaborole topical solution using the provided dropper. Do not use the dropper for any other purpose.

Step 3: With the dropper inserted into the tavaborole topical solution, squeeze the bulb and then release the bulb to draw tavaborole topical solution into the dropper.

Step 4: Remove the dropper from the bottle and hold the dropper tip over your affected toenail. Slowly squeeze the bulb to apply tavaborole topical solution to your toenail. Apply enough solution to completely cover your toenail. You may need to use more than one drop. (See Figure C)

Figure C

Step 6: Use the dropper tip to gently spread tavaborole topical solution to cover the entire toenail up to the edges of the toenail. (See Figure D)

Figure D

Step 7: In addition to the top of the toenail, also apply tavaborole topical solution under the tip of the toenail. Use the dropper tip to gently spread tavaborole topical solution under the entire tip of the toenail. (See Figures E and F)

Figure E Figure F

Step 8: Repeat Steps 3 to 7 to apply tavaborole topical solution to each affected toenail.

Step 9: Let the tavaborole topical solution dry completely. This may take a couple of minutes. Avoid getting tavaborole topical solution on skin that is not surrounding skin, use a tissue to wipe any excess solution from the surrounding skin. Do not wipe tavaborole topical solution off of your toenails.

Step 10: After applying tavaborole topical solution to your toenails, insert the dropper back into the bottle and screw it on tightly.

Step 11: Wash your hands with soap and water after applying tavaborole topical solution.

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