Uses of Tavaborole:

• It is used to treat fungal infections of the toenails.

What do I need to tell my doctor BEFORE I take Tavaborole?

• If you are allergic to tavaborole; any part of tavaborole; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tavaborole with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tavaborole?

• Tell all of your health care providers that you take tavaborole. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before using nail polish or other nail products like fake nails while using tavaborole.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tavaborole while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Tavaborole) best taken?

Use tavaborole as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take tavaborole by mouth. Use on your nails only. Keep out of your mouth, nose, and eyes (may burn).
• Before putting tavaborole on, clean the nails and dry well.
• Put tavaborole on the whole nail and under the tip of each treated nail.
• Let dry before covering with clothing.
• Wash hands after use.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where tavaborole is used.
• Ingrown toenail.

What are some other side effects of Tavaborole?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where tavaborole is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tavaborole?

• Store at room temperature.
• Protect from heat or open flame.
• Store in a dry place. Do not store in a bathroom.
• Throw away any part of tavaborole not used 3 months after first putting in the dropper.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tavaborole, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.