Pramoxine Gel

Pramoxine Gel is used for:

Temporarily relieving pain and itching caused by minor skin irritations, minor cuts and burns, sunburn, insect bites, scrapes, and rashes caused by poison ivy, oak, or sumac.

Pramoxine Gel is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.

Do NOT use Pramoxine Gel if:

• you are allergic to any ingredient in Pramoxine Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pramoxine Gel:

Some medical conditions may interact with Pramoxine Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Pramoxine Gel. Because little, if any, of Pramoxine Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Pramoxine Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pramoxine Gel:

Use Pramoxine Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash the affected area with soap and water, and gently pat dry.
• Apply Pramoxine Gel to the affected area as directed by your doctor or on the package labeling.
• Wash your hands immediately after using Pramoxine Gel, unless your hands are a part of the treated area.
• If you miss a dose of Pramoxine Gel, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pramoxine Gel.

Important safety information:

• Pramoxine Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 7 days, if they become worse, or if they clear up and then come back, check with your doctor.
• Do not apply Pramoxine Gel over large areas of your body without first checking with your doctor.
• Do not use Pramoxine Gel in CHILDREN younger than 2 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pramoxine Gel while you are pregnant. It is not know if Pramoxine Gel is found in breast milk. If you are or will be breast-feeding while you use Pramoxine Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pramoxine Gel:

All medicines may cause side effects, but many people have no, or minor side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Pramoxine Gel may be harmful if swallowed.

Store in an upright position at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Keep Pramoxine Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Pramoxine Gel, please talk with your doctor, pharmacist, or other health care provider.
• Pramoxine Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pramoxine Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.