Fluoroplex label

Fluoroplex

Fluoroplex Recall

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Side Effects & Adverse Reactions

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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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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

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History

There is currently no drug history available for this drug.

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Other Information

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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Fluoroplex Manufacturers

  • Aqua Pharmaceuticals, Llc
    Fluoroplex | Aqua Pharmaceuticals, Llc
    No Recall

    Fluoroplex | Aqua Pharmaceuticals, Llc

    Fluoroplex | Aqua Pharmaceuticals, Llc

    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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