PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-40 Cream Carton NDC 0187-3204-47Rx onlyEfudex(R) (fluorouracil)Topical Cream5%Net Wt. 40 gFOR TOPICAL USE ONLYNOT FOR OPHTHALMIC,ORAL, OR INTRAVAGINAL USEOrtho 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 weight/weight basis, compounded with disodium edetate, hydroxypropyl cellulose, methylparaben, propylene glycol, propylparaben, and tris (hydroxymethyl) aminomethane.EFUDEX Cream contains 5% fluorouracil in vanishing cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum.Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is 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.