Capsaicin/Menthol Patch

Capsaicin/Menthol Patch is used for:

Temporary relief of muscle and joint pain associated with arthritis, simple backaches, sprains, strains, and bruises. It may also be used for other conditions as determined by your doctor.

Capsaicin/Menthol Patch is a topical analgesic. Exactly how it works is unknown, but it is thought to decrease the amount of a certain substance (substance P) that transmits pain in the body.

Do NOT use Capsaicin/Menthol Patch if:

• you are allergic to any ingredient in Capsaicin/Menthol Patch

Contact your doctor or health care provider right away if this applies to you.

Before using Capsaicin/Menthol Patch:

Some medical conditions may interact with Capsaicin/Menthol Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an open wound or damaged, broken, or irritated skin

Some MEDICINES MAY INTERACT with Capsaicin/Menthol Patch. Because little, if any, of Capsaicin/Menthol Patch is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Capsaicin/Menthol Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Capsaicin/Menthol Patch:

Use Capsaicin/Menthol Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Capsaicin/Menthol Patch. Talk to your pharmacist if you have questions about this information.
• Apply Capsaicin/Menthol Patch right away after you remove it from the sealed package. Do not use a patch if the package is not sealed.
• Remove backing from patch by grasping both ends firmly and gently pulling until the backing separates in middle. Carefully remove backing from patch and apply to the affected area.
• Wash your hands with soap and water immediately after you apply the patch.
• Do not apply more than 4 times daily.
• Do not apply to wounds or damaged, broken (open), or irritated skin.
• Do not bandage or wrap the affected area.
• Do not use Capsaicin/Menthol Patch with a heating pad.
• Do not expose the treated area to heat or direct sunlight. Warm or hot water or sunlight may increase the likelihood of burning or itching. Do not use Capsaicin/Menthol Patch immediately after bathing, swimming, using a hot tub, sunbathing, or exposure to heat.
• If you miss a dose of Capsaicin/Menthol Patch, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Capsaicin/Menthol Patch.

Important safety information:

• For external use only. Avoid contact with the eyes, nose, and mouth. If Capsaicin/Menthol Patch gets into your eyes, rinse immediately with cool water.
• Do not exceed the recommended dose, use Capsaicin/Menthol Patch for longer than prescribed, or use large amounts of Capsaicin/Menthol Patch without checking with your doctor.
• Capsaicin/Menthol Patch may be harmful if swallowed. If you may have taken Capsaicin/Menthol Patch by mouth, contact your local poison control center or emergency room immediately.
• If condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use of this product and contact your health care provider.
• If redness is present or if irritation develops, check with your doctor before using any more of Capsaicin/Menthol Patch.
• If severe burning or itching occurs, remove product by thoroughly washing the area with soap and cold water.
• Capsaicin/Menthol Patch should not be used in CHILDREN younger than 18 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Capsaicin/Menthol Patch while you are pregnant. It is not known if Capsaicin/Menthol Patch is found in breast milk. If you are or will be breast-feeding while you use Capsaicin/Menthol Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Capsaicin/Menthol Patch:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Capsaicin/Menthol Patch may be harmful if swallowed.

Store Capsaicin/Menthol Patch at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Capsaicin/Menthol Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Capsaicin/Menthol Patch, please talk with your doctor, pharmacist, or other health care provider.
• Capsaicin/Menthol Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Capsaicin/Menthol Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.