Reallief Gel-I (for the skin) is a combination product that is used for temporary relief of minor pain caused by arthritis, muscle cramps, sprains or strains, bruising, or backache.

Reallief Gel-I may also be used for purposes not listed in this medication guide.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor. The cream or gel forms of this medicine are usually applied to the affected area 3 or 4 times per day.

Apply a Reallief Gel-I skin patch to clean, dry skin. Press the patch firmly into place and wear it for up to 8 hours. Do not wear for more than 3 days and do not wear more than one skin patch at a time unless your doctor tells you to.

Do not take by mouth. Topical medicine is for use only on the skin. Do not apply to open wounds or on sunburned, windburned, dry, or irritated skin. Rinse with water if this medicine gets in your eyes or mouth.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after applying this medicine.

Do not cover treated skin with a tight bandage or heating pad.

Camphor and menthol can cause a burning or cold sensation, which is usually mild and should lessen over time with continued use. If this sensation causes significant discomfort, wash the skin with soap and water.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• symptoms that do not improve after 7 days;

• symptoms that clear up and then return;

• minor pain with redness in the area of the skin where the medicine was applied; or

• your condition gets worse.

Store at room temperature away from moisture and heat. Protect from direct sunlight.

You should not use Reallief Gel-I if you are allergic to it, or to salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

The skin patch may contain latex and could be harmful if you have a latex allergy. Ask your doctor or pharmacist if the skin patch is safe to use.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• a heart disease;

• stomach bleeding;

• redness over the areas where you have minor pain; or

• kidney disease.

Ask a doctor or pharmacist before using this medicine on a child.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you breastfeed, avoid applying this medicine to your nipple area.

Reallief Gel-I is used when needed and does not have a daily dosing schedule. Do not use the product more often than directed on the label.

An overdose of Reallief Gel-I is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Do not get this medicine in your eyes, nose, or mouth. If contact does occur, rinse with water.

Drinking alcohol may increase your risk of stomach bleeding.

Avoid using other topical pain relief medications, unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have severe burning, stinging, irritation, pain, swelling, rash, or blistering where the medicine was applied.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.