Ingenol mebutate Topical gel

What is this medicine?

INGENOL MEBUTATE (IN jen ol MEB ue tate) is used on the skin to treat actinic keratosis.

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

What should I tell my health care provider before I take this medicine?

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

• skin conditions or sensitivity

• skin infection

• an unusual or allergic reaction to ingenol mebutate, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Let the medicine dry for 15 minutes after application. Do not wash or touch the treated area or do anything that causes excessive sweating for 6 hours after use. After 6 hours, the treated area of skin may be washed with mild soap. Use your medicine at regular intervals. Do not use it more often than directed. Finish the full course prescribed by your doctor or health care professional even if you think your condition is better. Do not stop using except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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 medicine?

Interactions are not expected. Do not use any other skin products on the same area of skin 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 medicine?

Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water and seek medical help as soon as possible.

This medicine can make certain skin conditions worse. Only use it for conditions for which your doctor or health care professional has prescribed.

This medicine can transfer from your body to others. If a person or pet comes in contact with the area where this medicine was applied to your skin, they may have a risk of side effects. If you cannot avoid skin-to-skin contact with another person, make sure the site where this medicine was applied is covered with clothing. If accidental contact happens, the skin of the person or pet should be washed right away with soap and water.

What side effects may I notice from receiving this medicine?

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

• eye pain

• open sores on the skin

• redness of the skin

• swelling of the skin

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

• headache

• itching

• skin irritation after application

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 medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. 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.