This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Talk to your doctor about the risks and benefits of ingenol, as well as alternative treatments for your condition.

This drug has been withdrawn from the Canadian market due to problems with safety.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on the skin as directed by your doctor. Do not use on irritated skin or skin that has not healed from other treatments or surgery. Do not apply right after taking a shower or less than 2 hours before bedtime.

The strength prescribed and treatment time depends on the application site. For use on the face or scalp, apply to the affected area(s) once a day for three days in a row. For use on your body, arms, hands, or legs, apply to the affected area(s) once a day for 2 days in a row. After spreading evenly on the treatment area, let the medication dry for 15 minutes. Wash your hands right away with soap and water. Avoid getting the drug on other areas, including near the eyes, lips, or mouth. If you accidentally get ingenol in your eyes, flush them well with large amounts of water and get medical care right away. Avoid washing and touching the treated area, or doing activities that cause excessive sweating, for 6 hours after application. After this time, you may wash the area with a mild soap.

Use a new tube of gel for each use. Throw away any open tube after use even if there is medication still left in it.

Even after washing your hands, the medication can remain on your hands and be transferred to your skin or eyes. Care should be taken when applying make-up or inserting contact lenses.

The treated area commonly becomes red or irritated during treatment. Skin reactions will usually improve after 2 to 4 weeks. Do not cover the area with bandages or other dressings.

Do not use more ingenol than you need to cover the treatment area or use it more often than directed. Your condition will not clear faster, and the risk of skin reactions will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Skin redness, itching, irritation, flaking/peeling, crusting, pain, or swelling commonly occur at the site of application. Eye/eyelid, nose, or throat irritation or headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including:

• blisters/pus/ulcers at the application site
• new or changed skin growths
• new scaly red patches on your skin

Get medical help right away if you have any very serious side effects, including:

• painful rash (especially on one side of the face or body)
• vision changes (including increased sensitivity to light, vision loss)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 ingenol, tell your doctor or pharmacist if you are allergic to it; 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:

• other skin problems (including sunburn) in the treatment area

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Keep all dermatology appointments, as regular check-ups are needed for your skin condition.

Discard any unused medication when the treatment is finished. Do not use it for any other skin conditions unless directed to do so by your doctor.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in a refrigerator. Do not freeze. Keep all medications 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.