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NDC 51672-4118-06

Fluorouracil 50 mg/g CREAM

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NDC
51672-4118-06
Generic Name
Fluorouracil
Brand Name
Fluorouracil
Strength
50 mg/g
Dosage Form
CREAM
Route
TOPICAL
Package Size
Labeler
Taro Pharmaceuticals U.S.A., Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of…

Important Warnings

WARNINGS Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when fluorouracil was applied to mucous membrane areas during pregnancy. Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of seve…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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