NDC Code(s) : 58980-680-50, 58980-680-90
Packager : Stratus Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RemevenUrea CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-680
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea(UNII: 8W8T17847W)
(Urea - UNII:8W8T17847W) 		Urea71 g in 142 g
Inactive Ingredients
Ingredient Name Strength
Edetate Disodium(UNII: 7FLD91C86K)
Glycerin(UNII: PDC6A3C0OX)
Lactic Acid(UNII: 33X04XA5AT)
Mineral Oil(UNII: T5L8T28FGP)
Water(UNII: 059QF0KO0R)
Sodium Hydroxide(UNII: 55X04QC32I)
Stearic Acid(UNII: 4ELV7Z65AP)
Pyrithione Zinc(UNII: R953O2RHZ5)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58980-680-501 in 1 BOX
1142 g in 1 TUBE
2NDC:58980-680-901 in 1 BOX
2255 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/18/2008

PRINCIPAL DISPLAY PANEL

NDC 58980-680-50
Net WT. 5.0 oz (142g)

REMEVEN™ CREAM
(50 % UREA IN A CREAM BASE)

STRATUS
PHARMACEUTICALS INC

Rx only

Principal Display Panel - 142 g Carton