Four Pain Rx (topical)

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

Four Pain Rx may also be used for reasons not mentioned in this medication guide.

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

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

• aspirin;
• sulfa drugs; or
• sunscreen or other skin products that have para-aminobenzoic acid (PABA).

Ask a doctor or pharmacist if this medicine is safe for you 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 put the medicine on your chest, avoid areas that may touch the baby's mouth.

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

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 immediately 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.

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.

Since Four Pain Rx is used as needed, you might not have a set dosing schedule. If you miss a dose and it's close to the time for your next dose, just skip the missed dose. Do not use two doses at the same time.

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

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

Do not let this medicine touch your eyes, mouth, nose, genitals, or rectum. If it does, rinse with water. Avoid touching these areas until you have washed your hands.

Do not use other medications on the areas treated with Four Pain Rx unless your doctor instructs you to.

Medicine that you apply to your skin is not likely to interact with other drugs you take. However, many medications can affect each other. Make sure to inform all your healthcare providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.