Four Pain Rx (for the skin) is a combination medicine used for temporary relief of muscle pain and soreness than may be related to arthritis, strains, backaches, or bruises.

Four Pain Rx may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to aspirin, sulfa drugs, PABA (para-aminobenzoic acid).

Use exactly as directed on the label, or as prescribed by your doctor.

Do not take by mouth. Topical medicine is for use only on the skin.

Do not use on open wounds or on broken or infected skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Wash your hands with soap and water immediately after applying this medicine.

This medicine 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, redness, or skin irritation.

Shake the lotion before each use.

Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation.

Call your doctor if your pain does not improve after using this medicine for 7 days, or if your symptoms get worse.

To keep this medicine from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Store the medicine at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

You should not use this medicine if you are allergic to:

• aspirin;

• sulfa drugs; or

• sunscreen or other skin products that contain para-aminobenzoic acid (PABA).

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

• sensitive skin;

• an allergy to chili peppers;

• a blood cell disorder called methemoglobinemia (in you or a family member);

• heart problems;

• breathing problems; or

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Ask a doctor before using this medicine if you are pregnant or breastfeeding. If you apply the medicine to your chest, avoid areas that may come into contact with the baby's mouth.

Do not use this medicine on a child without medical advice. Four Pain Rx is not approved for use by anyone younger than 12 years old.

Since Four Pain Rx 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.

Do not use Four Pain Rx more than 4 times per day.

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

Do not get this medicine in your eyes, mouth, nose, genitals, or rectum. If contact does occur, rinse with water. Avoid touching these areas until the medicine has been washed off your hands.

Avoid using other medications on the areas you treat with Four Pain Rx unless your doctor tells you to.

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

Wash the skin and get medical attention right away if you have severe burning, pain, swelling, or blistering of the skin where you applied this medicine.

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

• pale skin, blue-colored lips;

• headache, confusion; or

• rapid heartbeats.

Common side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of this medicine.

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 with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.