Fluorouracil Topical Cream

FLUOROPLEX® (fluorouracil) 1% Topical Cream is an antineoplastic/antimetabolite product for dermatological use. Fluorouracil has the empirical formula C4H3FN2O2 and a molecular weight of 130.08. It is sparingly soluble in water and slightly soluble in alcohol. The pH is approximately 8.5.

Structural Formula:

fluorouracil

Chemical Name:

2,4(1H,3H)-Pyrimidinedione, 5-fluoro-.

FLUOROPLEX (fluorouracil topical cream) ® 1% Topical Cream contains:

Active Ingredient: fluorouracil 1.0%

Inactive Ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide .

FLUOROPLEX® (fluorouracil) 1% Topical Cream is available in 30 g tubes (NDC 0023-081230)

NOTE: Avoid freezing. Store at 15° - 30°C (59° - 86°F) in tight containers.

Revised November 2004. Manufactured for: Allergan, Inc. Irvine, California 92612, U.S.A. By Contract Pharmaceuticals Limited Mississauga Ontario, Canada L5N 6L6

Ordinarily, overdosage will not cause acute problems. If FLUOROPLEX® (fluorouracil topical cream) Cream accidentally comes in contact with the eye(s), flush the eyes(s) with water or normal saline. If FLUOROPLEX® (fluorouracil topical cream) Cream is accidentally ingested, induce emesis and gastric lavage. Administer symptomatic and supportive care as needed.

Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported. Occasionally, hyperpigmentation and scarring have also been reported.

Read the entire FDA prescribing information for Fluoroplex (Fluorouracil Topical Cream)

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© Fluoroplex Patient Information is supplied by Cerner Multum, Inc. and Fluoroplex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

This medicine is only for use on the skin. Follow the directions on the prescription label. Wash hands before and after use. Wash affected area and gently pat dry. To apply this medicine use a cotton-tipped applicator, or use gloves if applying with fingertips. If applied with unprotected fingertips, it is very important to wash your hands well after you apply this medicine. Avoid applying to the eyes, nose, or mouth. Apply enough medicine to cover the affected area. You can cover the area with a light gauze dressing, but do not use tight or air-tight dressings. Finish the full course prescribed by your doctor or health care professional, even if you think your condition is better. Do not stop taking 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.

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

• DPD enzyme deficiency
• recent or current radiation therapy
• swelling or open sores at the treatment site
• an unusual or allergic reaction to fluorouracil, other chemotherapy, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, apply it as soon as you can. If it is almost time for your next dose, only use that dose. Do not apply extra doses. Contact your doctor or health care professional if you miss more than one dose.

Visit your doctor or health care professional for checks on your progress. You will need to use this medicine for 2 to 6 weeks. This may be longer depending on the condition being treated. You may not see full healing for another 1 to 2 months after you stop using the medicine.

Treated areas of skin can look unsightly during and for several weeks after treatment with this medicine.

Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep container tightly closed. Throw away any unused medicine after the expiration date.