Picato works by causing the death of certain cells in the body.

Picato gel is used to treat actinic keratosis (warty overgrowths of skin) on the face, scalp, arms, and legs.

Picato gel may also be used for purposes not listed in this medication guide.

Use Picato gel exactly as prescribed by your doctor. Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions. Follow the directions on your prescription label.

Wash your hands with soap and water before and after applying the gel. Do not use Picato on sunburned skin, or on areas of skin that are still healing after surgery or treatment with other medications. Wait until these conditions have healed before using this medicine. Do not get this medication in your eyes. If this does happen, rinse with water and call your doctor at once. Avoid getting the medication in your mouth or vagina. If it does get into any of these areas, rinse with water.

Avoid letting treated skin areas come into contact with other people. Avoid touching a treated skin area and then touching your eyes.

Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Apply Picato exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Do not apply Picato less than 2 hours before bedtime. Do not apply the medicine right after taking a shower.

Do not use on sunburned skin, or on areas of skin that are still healing after surgery or treatment with other medications. Wait until these conditions have healed before using Picato.

For 0.015% gel: To treat actinic keratosis on the face and scalp, apply once daily for 3 days in a row.

For 0.05% gel: To treat actinic keratosis on the arms and legs or trunk, apply once daily for 2 days in a row.

Wash your hands with soap and water after applying Picato.

Allow the skin to dry for at least 15 minutes after applying Picato.

Avoid touching or washing the treated skin for 6 hours after applying Picato. Avoid activities that may cause heavy sweating. After 6 hours have passed, you may wash the treated skin with a mild soap.

Call your doctor if your symptoms do not improve, or if they get worse.

Each tube of ingenol is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store this medicine in the refrigerator, do not freeze.

Usual Adult Dose for Keratosis:

Face and scalp: This drug should be applied to the affected area once a day for 3 consecutive days.
Trunk or extremities: This drug should be applied to the affected area once a day for 2 consecutive days.

Comments:
-This drug may be applied to the affected area, up to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm) using one unit dose tube.
-After spreading evenly over the treatment area, this drug should be allowed to dry for 15 minutes.
-Patients should wash their hands immediately after applying the drug and take care not to transfer the applied drug to other areas, including the eye.
-Patients should avoid washing and touching the treated area for a period of 6 hours after application. Following this time, patients may wash the area with a mild soap.
-This drug should not be applied orally, ophthalmically, or intravaginally.

Use: Inducer of cell death for the topical treatment of actinic keratosis

You should not use Picato if you are allergic to ingenol

Tell your doctor if you have ever been treated for actinic keratosis.

Tell your doctor if you are pregnant or breastfeeding.

If you apply Picato to your chest, avoid areas that may come into contact with the baby's mouth.

Picato is not approved for use by anyone younger than 18 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include skin reactions.

This medicine can cause serious eye problems if it gets in your eyes. Avoid touching your eyes after applying the medicine until you have washed your hands.

If contact does occur, rinse your eyes with water and call your doctor.

Avoid getting this medicine in your mouth or vagina.

Get emergency medical help if you have signs of an allergic reaction to Picato: hives; feeling light-headed, dizzy; difficulty breathing, wheezing, chest tightness; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe skin redness, flaking, scaling, crusting, swelling;

• blisters, pus, ulcers, or skin breakdown; or

• (if this medicine gets in your eye) eye pain, redness, burning, swelling around the eye, drooping eyelid.

Picato may cause scars or changes in skin color where the medicine was applied.

Common Picato side effects include:

• a skin reaction where you applied the medicine;

• pain, itching, irritation, or infection where the medicine was applied;

• swelling around the eyes;

• headache; or

• nose and throat irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.