NDC Code(s) : 0316-7405-08
Packager : Crown Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

rea lo 39urea CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0316-7405
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA(UNII: 8W8T17847W)
(UREA - UNII:8W8T17847W) 		UREA390 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLAWAX POLYSORBATE(UNII: Q504PL8E0V)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
SORBITOL(UNII: 506T60A25R)
TRIDECYL STEARATE(UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
TRIDECYL TRIMELLITATE(UNII: FY36J270ES)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0316-7405-081 in 1 CARTON
1227 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2014

PRINCIPAL DISPLAY PANEL

NDC 0316-7405-08
Rea Lo 39
(Urea 39%) Cream


For Topical Use Only
Rx Only

8 oz (227 g)

P1910.00

Rea Lo 39 Carton