Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID).

Diclotral Pak (for the skin) is a combination medicine used to treat joint pain, stiffness, and swelling caused by osteoarthritis of the knees. Diclotral Pak may not be effective in treating arthritis pain elsewhere in the body.

Diclotral Pak may also be used for purposes not listed in this medication guide.

Diclofenac can increase your risk of fatal heart attack or stroke. Do not use Diclotral Pak just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac may also cause stomach or intestinal bleeding, which can be fatal.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Diclotral Pak is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Do not apply to open wounds or to sunburned, chapped, irritated, or infected skin. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna.

Apply the solution only to clean, dry skin. Spread the solution over the front, back, and sides of the knee.

Wash your hands after applying this medicine. Wait at least 30 minutes before you bathe or shower.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products (cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products).

Do not allow others to touch the area where you have applied the medicine.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

If the burning sensation is painful or causes significant discomfort, wash the treated skin area with soap and cool water. Get medical attention right away if you have severe burning, pain, swelling, or blistering.

If you use this medicine long-term, you may need frequent medical tests.

Call your doctor if your arthritis symptoms do not improve after 7 days of treatment, or if your symptoms get better and then worse within a few days.

Store at room temperature away from moisture and heat.

Diclotral Pak solution is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Diclofenac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

You should not use this medicine if you are allergic to capsaicin or diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• fluid retention.

If you are pregnant, you should not use Diclotral Pak unless your doctor tells you to. Using an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

This medicine is not approved for use by anyone younger than 18 years old.

Since Diclotral Pak is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Avoid exposing treated skin to heat, sunlight, or tanning beds.

Avoid taking a bath or shower within 30 minutes before or after you apply Diclotral Pak to your skin. Also avoid vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

Avoid getting this medicine in your eyes, nose, or mouth.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Serious side effects are unlikely when Diclotral Pak is applied to the skin, but can occur if the medicine is absorbed into your bloodstream.

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.

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

• a skin rash, no matter how mild;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

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

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Diclotral Pak may include:

• skin rash, itching, redness, blistering, tingling, or other irritation where the medicine was applied; or

• dryness or hardening of treated skin.

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.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (prednisone and others).

This list is not complete. Other drugs may affect Diclotral Pak, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.