Tolak (fluorouracil) 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). 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.

• Prior to application of Tolak Cream, wash, rinse, and dry the treatment areas.
• Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin.
• Apply Tolak Cream for a period of 4 weeks as tolerated. Thoroughly wash hands following Tolak Cream application.
• Tolak Cream is for topical use only.
• Do not apply to eyes, nose, mouth or mucous membranes.
• Not for ophthalmic, oral or intravaginal use.

• Subjects using systemic steroids, immunosuppressants, and immunomodulators were generally excluded from the clinical studies of Tolak Cream, as were subjects who used retinoids, topical steroids, glycolic acid products, alpha-hydroxy products, and chemical peeling products in the treatment areas.
• No clinical trials were designed to specifically evaluate drug interactions.

• Cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported when pregnant women were exposed to a topical or parenteral fluorouracil product.
• In addition, ventricular septal defect and cases of miscarriage occurred when pregnant women applied a topical fluorouracil product to mucous membranes (Tolak Cream is not indicated for use on the mucous membrane).
• Because many drugs are excreted in human milk and there is some systemic absorption of fluorouracil after topical administration, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue drug use, taking into account the importance of the drug to the mother.