Camphor, lidocaine, and methyl salicylate topical

This medicine contains methyl salicylate, which is an NSAID. An NSAID can increase your risk of fatal heart attack or stroke, especially if you use it long term, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while using an NSAID.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

An NSAID may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using and NSAID, especially in older adults.

You should not use this medicine if you are allergic to camphor, lidocaine, or methyl salicylate.

To make sure camphor, lidocaine, and methyl salicylate is safe for you, tell your doctor if:

• you have high blood pressure or heart disease;

• you have ever had a stomach ulcer or bleeding problems;

• you drink 3 or more alcoholic drinks per day;

• you have kidney disease;

• you are allergic to any skin products; or

• you are allergic to any NSAID (aspirin, ibuprofen, celecoxib, diclofenac, indomethacin, meloxicam, naproxen, Advil, Motrin, Aleve, and others).

Do not use this medicine without a doctor's advice if you are pregnant. Using methyl salicylate during the last 3 months of pregnancy may harm the unborn baby, or cause bleeding in the mother or the baby during delivery.

It is not known whether camphor, lidocaine, or methyl salicylate could pass into breast milk or harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 12 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if a child has placed a skin patch into his or her mouth.

Do not expose treated skin to heat from a hot tub, heating pad, or sauna. Heat can increase the amount of drug absorbed through your skin and may cause harmful effects.

Rinse with water if the medicine gets in your eyes.

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

Remove the skin patch and get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Although the risk of serious side effects is low when medicine is applied to your skin, side effects can occur if the medicine is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have:

• worsening of your muscle pain;

• skin rash, itching, or irritation;

• a light-headed feeling, like you might pass out;

• new or worsening stomach pain; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

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.