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Important Safety Information Regarding FLUOROPLEX® (Fluorouracil) 1% Topical Cream
FLUOROPLEX® 1% Topical Cream is indicated for the topical treatment of multiple actinic (solar) keratoses. Fluorouracil should not be used by women who are or may become pregnant. This product should not be used by patients who are allergic to any of its ingredients. There exists the potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to prove hypersensitivity may be inconclusive. 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® 1% Topical Cream, as the intensity of the reaction may be increased. 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® 1% Topical Cream is applied with the fingers, and the hands should be washed immediately afterward. The reaction to FLUOROPLEX® 1% Topical Cream in treated areas may be unsightly during therapy, and, in some cases, for several weeks following cessation of therapy. Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis, and telangiectasia have been reported. Occasionally, hyperpigmentation and scarring have also been reported.