Epifoam

This product contains 2 medications. Pramoxine is an anesthetic that is used on the skin to relieve minor pain, itching, and discomfort. It works by temporarily numbing the area. Hydrocortisone is a corticosteroid that reduces redness, swelling, and itching. This combination medication is used to treat certain skin conditions such as eczema, psoriasis, rash, cuts, scrapes, insect bites, or minor burns. This product is available in different strengths and forms (e.g., aerosol foam, cream, ointment, lotion). The type of medication used depends on the location of your condition and the type of skin problem being treated. Creams are the most frequently used form. Lotions may be better for hairy areas. Ointments may be better for dry areas and when a stronger effect or skin protection is desired. Foams can be easier and less messy to apply.

Follow all instructions in the product package, including any instructions for cleaning the container after use. Before each use, shake the foam canister well for 5-10 seconds. Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Apply a small amount of the foam to the affected area, usually 3-4 times a day or as directed by your doctor. You may need to press the applicator a few times before foam appears. You can apply the foam directly to the area, or apply a small amount to a pad and use it to apply the foam to the affected area. Do not use the foam or insert any part of the foam canister in the anus or vagina.

This medication is for use on the skin only, as directed by your doctor. Do not use more of this product, use it more often, or keep using it longer than prescribed because doing so may increase the risk of side effects. Wash hands immediately after use, unless the area being treated includes the hands. Avoid getting the product in your eyes, nose, ears or mouth. If the medication gets in these areas, rinse the area immediately with clean water.

Do not cover the area with waterproof bandages or plastic, apply heat, or use the product on large areas of the body unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants. These may increase the risk of side effects.

How often the medication is applied and for how long depends on your condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not improve or if it worsens.

Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: change in skin appearance (such as its color, thickness), signs of skin infection (such as a feeling of heat at the area, tenderness, pus).

Tell your doctor right away if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to hydrocortisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (e.g., low white blood cells), diabetes, infections (especially skin infections), kidney disease, liver disease.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. It should not be used for a long time or in large amounts. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Store the foam canister upright at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Do not refrigerate. Do not store above 120 degrees F (49 degrees C). The contents of this container are under pressure. Do not burn or puncture the aerosol container. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroids/immunosuppressants (e.g., prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Tell all your doctors that you use (or have used) this medication.