NDC Code(s) : 69336-801-60
Packager : Sterling Knight Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

UREVAZUrea Cream 44% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-801
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA(UNII: 8W8T17847W)
(UREA - UNII:8W8T17847W) 		UREA440 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES(UNII: GO50W2HWO8)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69336-801-601 in 1 CARTON
160 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/21/2015

PRINCIPAL DISPLAY PANEL

Urea Cream, 44 %

For External Use Only. Not for Ophthalmic Use.

Rx Only

urevaz