Hydrocortisone; Pramoxine Topical Aerosol Foam

What is this medication?

HYDROCORTISONE; PRAMOXINE (hye droe KOR ti sone; pra MOX een) is a combination of a corticosteroid and an anesthetic. It is used to decrease swelling, itching and pain of the skin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Epifoam, ProctoFoam HC

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• any active infection
• large areas of burned or damaged skin
• kidney disease
• liver disease
• skin wasting or thinning
• an unusual or allergic reaction to hydrocortisone, corticosteroids, pramoxine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for external use only. Do not take by mouth. Follow directions on the prescription label. Wash hands before and after use. Shake the container for 5 to 10 seconds before each use. Gently cleanse the affected area prior to use. While holding the container upright prime the container by pressing down several times on container cap until foam appears. Dispense foam onto a cleansing tissue or pad and gently rub into the affected area. The container and cap should be disassembled and rinsed with warm water after each use. Do not use on healthy skin or over large areas of skin. Do not use an airtight bandage to cover the affected area unless your doctor or health care professional tells you to. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not use your medicine more often than directed. Do not use for more than 14 days.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply. If applying this medicine to the diaper area of a child, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medicine that passes through the skin and increase the risk of serious side effects.

Elderly patients are more likely to have damaged skin through aging, and this may increase side effects. This medicine should only be used for brief periods and infrequently in older patients.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the affected area without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care professional if your symptoms do not start to get better within one week. Tell your doctor or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

Do not use near heat, open flame, or while smoking.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•dark red spots or bumps on the skin

•lack of healing of skin

•skin infection

•skin irritation

•thinning of the skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•burning or stinging sensation

•dryness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not refrigerate or freeze. Store the container upright. Contents of the container are under pressure. Do not incinerate or puncture the aerosol container. Do not store at temperature above 120 degrees F. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.