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FDA Drug information

Efudex

Read time: 1 mins
Marketing start date: 03 May 2024
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Summary of product characteristics


Effective Time

20211020

Version

17

Spl Product Data Elements

Efudex Fluorouracil Fluorouracil Fluorouracil propylene glycol Tromethamine methylparaben propylparaben edetate disodium HYDROXYPROPYL CELLULOSE (110000 WAMW) Efudex Fluorouracil Fluorouracil Fluorouracil propylene glycol Tromethamine methylparaben propylparaben edetate disodium HYDROXYPROPYL CELLULOSE (110000 WAMW) Efudex Fluorouracil Fluorouracil Fluorouracil methylparaben polysorbate 60 propylene glycol propylparaben WATER stearyl alcohol petrolatum

Application Number

NDA016831

Brand Name

Efudex

Generic Name

Fluorouracil

Product Ndc

0187-3204

Product Type

HUMAN PRESCRIPTION DRUG

Route

TOPICAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-40 g Cream Carton NDC 0187-3204-47 Rx only Efudex ® (fluorouracil) Topical Cream 5% Net Wt. 40 g FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE Ortho Dermatologics carton

Spl Unclassified Section

DESCRIPTION: EFUDEX Topical Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. EFUDEX Topical Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with disodium edetate, hydroxypropyl cellulose, methylparaben, propylene glycol, propylparaben, and tris (hydroxymethyl) aminomethane. EFUDEX Cream contains 5% fluorouracil in a vanishing cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Chemically, fluorouracil is a 5-fluoro-2,4(1 H ,3 H )-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is: Efudex chemical structure

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