Label: FLUOROPLEX- fluorouracil cream 

  • Label RSS
  • NDC Code(s): 16110-812-30
  • Packager: Aqua Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 11/12

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  • DESCRIPTION

    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:

    Chemical Structure

    fluorouracil

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

    FLUOROPLEX® 1% Topical Cream contains:

    Active Ingredient: fluorouracil 1.0%

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

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  • CLINICAL PHARMACOLOGY

    There is evidence that fluorouracil (or its metabolites) blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this fashion, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA).

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  • INDICATIONS AND USAGE

    FLUOROPLEX® Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.

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  • CONTRAINDICATIONS

    Fluorouracil is contraindicated in women who are or may become pregnant.

    This product should not be used by patients who are allergic to any of its components.

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  • WARNINGS

    There exists the potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to prove hypersensitivity may be inconclusive1.

    If an occlusive dressing is used, there may be an increase in the incidence of inflammatory reactions in the adjacent normal skin.

    The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with FLUOROPLEX® Cream, as the intensity of the reaction may be increased.

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  • PRECAUTIONS

    General

    There is a possibility of increased absorption through ulcerated or inflamed skin.

    Information for patients

    The medication should be applied with care near the eyes, nose, and mouth. Excessive reaction in these areas may occur due to irritation from accumulation of drug. FLUOROPLEX® Cream is applied with the fingers, and the hands should be washed immediately afterward. The reaction to FLUOROPLEX® Cream in treated areas may be unsightly during therapy, and, in some cases, for several weeks following cessation of therapy.

    Laboratory Tests

    To rule out the presence of a frank neoplasm, a biopsy should be made of those areas failing to respond to treatment or recurring after treatment.

    Carcinogenesis, mutagenesis, impairment of fertility

    Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. In three in-vitro cell transformation assays, fluorouracil produced morphological transformation of cells. Morphological transformation was also produced in one of these in-vitro assays by a metabolite of fluorouracil and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic acitivity in the yeast cells, Bacillus subtilis and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay and increases in micronuclei formation in the bone marrow of mice at intraperitoneal doses within the human therapeutic dose range of 12-15 mg/kg/day. Patients receiving cumulative doses of 0.24-1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes. Fluorouracil has been shown to impair fertility after parenteral administration in rats. In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg.

    Fluorouracil was negative in the dominant lethal mutation assay performed in mice.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category X

    Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats and hamsters, and embryolethal in monkeys. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

    Nursing mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because there is some systemic absorption of fluorouracil after topical administration (see PRECAUTIONS: General), mothers should not nurse their infants while receiving this drug.

    Pediatric use

    Safety and effectiveness in pediatric patients have not been established.

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  • ADVERSE REACTIONS

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

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  • OVERDOSAGE

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

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  • DOSAGE AND ADMINISTRATION

    The patient should be instructed to apply sufficient medication to cover the entire face or other affected areas.

    Apply medication twice daily with fingertips and wash hands afterwards. A treatment period of 2-6 weeks is usually required.

    Increasing the frequency of application and a longer period of administration with FLUOROPLEX® Cream may be required on areas other than the head and neck.

    When FLUOROPLEX® Cream is applied to keratotic skin, a response occurs with the following sequence: erythema, usually followed by scaling, tenderness, erosion, ulceration, necrosis and re-epithelization. When the inflammatory reaction reaches the erosion, ulceration and necrosis stages, the use of the drug should be terminated. Responses may sometimes occur in areas which appear clinically normal. These may be sites of subclinical actinic (solar) keratosis which the medication is affecting.

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  • HOW SUPPLIED

    FLUOROPLEX® (fluorouracil) 1% Topical Cream is available in 30 g tubes (NDC 16110-812-30)

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

    Rx Only

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  • REFERENCE

    1. Epstein E. Testing for 5-fluorouracil allergy: patch and intradermal tests. Contact Dermatitis 1984; 10:311.
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  • SPL UNCLASSIFIED SECTION

    Revised March 2012

    Manufactured for:
    Aqua Pharmaceuticals
    West Chester, PA 19380, U.S.A.
    By:
    Contract Pharmaceuticals Limited
    Mississauga
    Ontario, Canada
    L5N 6L6
    ® Marks owned by Aqua Pharmaceuticals
    Printed in U.S.A.

    4716X
    2005931

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  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    30 grams

    Fluoroplex®
    (fluorouracil) 1%
    Topical Cream

    NDC 16110-812-30

    Contains:
    Active:
    fluorouracil 1.0%
    Inactives: benzyl alcohol; emulsifying wax; mineral
    oil; isopropyl myristate; sodium hydroxide; and
    purified water.

    Rx Only

    AQUA
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    FLUOROPLEX 
    fluorouracil cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16110-812
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    fluorouracil (fluorouracil) fluorouracil 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    ISOPROPYL MYRISTATE  
    mineral oil  
    water  
    sodium hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16110-812-30 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016988 12/03/1993
    Labeler - Aqua Pharmaceuticals, LLC (605425912)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmaceuticals Limited Canada 248761249 MANUFACTURE(16110-812), PACK(16110-812), ANALYSIS(16110-812)
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