FLUOROPLEX® (fluorouracil) 1% Topical Cream, is indicated for the topical treatment of multiple actinic (solar) keratoses.
Click here for Full Prescribing Information for FLUOROPLEX® Topical Cream.Important Safety Information Regarding FLUOROPLEX® (Fluorouracil) 1% Topical Cream
- FLUOROPLEX® Topical Cream should not be used by women who are or may become pregnant. FLUOROPLEX® Topical Cream may cause fetal harm when administered to a pregnant woman. 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.
- FLUOROPLEX® Topical Cream should not be used by patients who are allergic to any of its components.
- There exists the potential for a delayed hypersensitivity reaction to FLUOROPLEX® Topical Cream. Patch testing to prove hypersensitivity may be inconclusive.
- The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with FLUOROPLEX® Topical Cream as the intensity of the reaction may be increased.
- It is not known whether FLUOROPLEX® Topical Cream is excreted in human milk. Because many drugs are excreted in human milk, and because there is some systemic absorption of FLUOROPLEX® Cream after topical administration, mothers should not nurse their infants while receiving this drug.
- Safety and efficacy in pediatric patients have not been established.
- Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis, and telangiectasia have been reported with use of FLUOROPLEX® Topical Cream. Occasionally, hyperpigmentation and scarring have also been reported.
Click here for Full Prescribing Information for FLUOROPLEX® Topical Cream.
To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.