Tavaborole 5% Topical Solution- 10ml

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TAVABOROLE - TOPICAL

(TA-va-BOR-ole)

COMMON BRAND NAME(S): Kerydin

USES: This medication is used to treat toenail infection caused by fungus. It works by stopping the growth of certain types of fungus. Tavaborole belongs to a class of drugs known as oxaborole antifungals. This medication treats only fungal infections. It will not work for other types of infection, such as those caused by bacteria. Unnecessary use or misuse of any drug used to treat infection can lead to its decreased effectiveness.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using tavaborole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before applying this medication, clean and dry the infected toenail(s). Use this medication only on the infected toenail(s) as directed by your doctor, usually once daily for 48 weeks. If this medication is used on a child, an adult should apply it for them. Using the provided dropper, apply to the infected toenail(s). Slowly squeeze the bulb to apply enough solution to completely cover your toenail. Use the dropper tip to gently spread the medication over the toenail up to the edges, and under the tip of the toenail. Repeat for each affected toenail. After applying, wait about 2 minutes to let the solution dry completely before wearing socks, shoes, or other footwear. If the solution comes in contact with skin around the toenail(s), use a tissue to wipe any excess solution from the surrounding skin. Wash your hands with soap and water after applying the medication. Avoid getting this medication on any other part of your body. If this accidentally happens, wipe off the medication and rinse thoroughly with water. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Nail fungus treatment usually must be continued a long time so that healthy nails can grow and replace the infected toenail(s). Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition does not improve or if it worsens. Since this product can catch on fire, do not use it near heat or an open flame (see also Storage section).

SIDE EFFECTS: Application site irritation, redness, itching, swelling, or skin peeling may occur. Ingrown toenails may also occur. If any of these effects last or get worse, stop using this medication and tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tavaborole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not apply more of this medication to try to catch up.

STORAGE: Store the bottle tightly closed and in an upright position at room temperature. Do not freeze. This product can catch on fire. Keep away from heat or open flame. Keep all medications away from children and pets. After opening, discard any unused product after 3 months. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2024. Copyright(c) 2024 First Databank, Inc.