Important Safety Information

Important: Tolak Cream is for use on skin only (topical).

Do not get or apply Tolak Cream on your eyelids or in your eyes, nose, mouth, or in the vagina, because it may cause irritation and swelling in these areas.

What is Tolak Cream?

  • Tolak Cream is a prescription medicine used to treat skin lesions called actinic keratosis on the face, ears, or scalp.
  • It is not known if Tolak Cream is safe and effective for use on other areas of the body or to treat problems other than actinic keratosis.
  • It is not known if Tolak Cream is safe and effective in children.

Who should not use Tolak Cream?

Do not use Tolak Cream if:

  • you are pregnant or may become pregnant. Tolak Cream may harm your unborn child. Stop using Tolak Cream and tell your doctor right away if you become pregnant while using Tolak Cream.
  • your body does not make enough of (you are deficient in) the enzyme called dihydropyrimidine dehydrogenase (DPD). If you do not have enough of this enzyme, you may get serious side effects if you use Tolak Cream. Symptoms of serious side effects include: stomach-area abdominal pain, bloody diarrhea, vomiting, fever, and chills.

What should I tell my doctor before using Tolak Cream?

Before using Tolak Cream, tell your doctor about all your medical conditions, including if you:

  • are allergic to any of the ingredients in Tolak Cream. Tolak Cream contains peanut oil. See the end of this leaflet for a list of all of the ingredients in Tolak Cream.
  • are pregnant or plan to become pregnant. See “Who should not use Tolak Cream?”
    • Females who are able to become pregnant should use an effective method of birth control during treatment with Tolak Cream and for one month after the last dose of Tolak Cream. Talk to your doctor about birth control methods that may be right for you during treatment with Tolak Cream.
  • are breastfeeding or plan to breastfeed. It is not known if Tolak Cream passes into your breast milk. You and your doctor should decide if you will use Tolak Cream or breastfeed.

How should I use Tolak Cream?

  • Use Tolak Cream exactly as prescribed by your doctor.
  • Apply Tolak Cream 1 time each day, to the areas of your skin to be treated, for 4 weeks. Apply Tolak Cream as follows:
    • Gently wash, rinse, and pat dry the skin areas to be treated.
    • Apply a thin film of the Tolak Cream to the areas to be treated.
    • Gently massage Tolak Cream evenly into your skin.
    • Avoid contact with other areas of your body, and transfer of Tolak Cream from your body to other people.
    • Wash your hands well after you apply Tolak Cream.

What should I avoid while using Tolak Cream?

  • Do not cover the treated areas with an airtight dressing.
  • Avoid sunlight. Tolak Cream can make your skin sensitive to the sun. You could get severe sunburn. Limit your time in the sun during treatment with Tolak Cream. Talk to your doctor if you get sunburn.

What are the possible side effects of Tolak Cream?

Tolak Cream can cause serious side effects:

  • Skin reactions including possible allergic reactions. Most people using Tolak Cream get skin reactions in the treated areas. You may get skin reactions such as:
    • redness
    • dryness or scaling
    • crusting
    • itching
    • stinging or burning
    • swelling
    • skin loss (erosion)
  • Eye problems. Eye problems have happened with the use of medicines that contain fluorouracil that are applied to the skin. To help prevent getting Tolak Cream in your eyes, or transferring Tolak Cream from another part of your body to your eyes or to another person’s eyes:
    • avoid applying Tolak Cream near or around your eyes
    • wash your hands well after you apply Tolak Cream

If you accidentally get Tolak Cream in your eyes, or if Tolak Cream is accidentally transferred to another person’s eyes, flush eyes with large amounts of water and get medical help as soon as possible.

  • Tolak Cream can cause serious side effects in people who do not have enough of the enzyme dihydropyrimidine dehydrogenase (DPD). See “Who should not use Tolak Cream?” and “What should I tell my doctor before using Tolak Cream?” Stop using Tolak Cream and call your doctor right away if you get any of the following symptoms during treatment with Tolak Cream:
    • stomach-area (abdominal) pain
    • bloody diarrhea
    • vomiting
    • fever
    • chills

Tell your doctor if you get any of these skin reactions and they are severe or do not go away.

These are not all the possible side effects of Tolak Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tolak Cream?

  • Store Tolak Cream between 68°F to 77°F (20°C to 25°C).
  • Do not freeze Tolak Cream.
  • Do not use Tolak Cream after the expiration date printed on the tube.

Keep Tolak Cream and all medicines out of the reach of children.

General information about the safe and effective use of Tolak Cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tolak Cream for a condition for which it was not prescribed. Do not give Tolak Cream to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or doctor for information about Tolak Cream that is written for health professionals.

What are the ingredients in Tolak Cream?

Active ingredient

  • fluorouracil

Inactive ingredients

  • arlacel-165
  • butylated hydroxytoluene
  • cetyl alcohol
  • anhydrous citric acid
  • glycerin
  • isopropyl myristate
  • methyl gluceth-10
  • methylparaben
  • propylparaben
  • purified water
  • peanut oil
  • sodium hydroxide
  • stearic acid
  • stearyl alcohol

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You may also report side effects to Pierre Fabre Pharmaceuticals, Inc. at 1-855-MYTOLAK (1-855-698-6525).

This site is intended for US residents age 18 and older.

© Pierre Fabre Pharmaceuticals, Inc. | http://www.pierre-fabre.com/en | 8 Campus Dr, Parsippany, NJ 07054

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