NDC Code(s) : 58980-473-10
Packager : Stratus Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Melpaque HPHydroquinone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-473
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone(UNII: XV74C1N1AE)
(Hydroquinone - UNII:XV74C1N1AE) 		Hydroquinone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
Stearic Acid(UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
SQUALENE(UNII: 7QWM220FJH)
Mineral Oil(UNII: T5L8T28FGP)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
EDETATE SODIUM(UNII: MP1J8420LU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Talc(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PEG-25 PROPYLENE GLYCOL STEARATE(UNII: X21KPH4633)
Product Characteristics
Color ORANGE (Rust Colored) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58980-473-101 in 1 BOX
128.35 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 04/02/2001

PRINCIPAL DISPLAY PANEL

NDC 58980-473-10
Net WT. 1 oz (28.35g)

WITH SUNBLOCKS

MELPAQUE ® HP 4% CREAM
(HYDROQUINONE USP, 4%)

STRATUS
PHARMACEUTICALS INC

SKIN BLEACHING CREAM WITH SUNBLOCKS

Distributed by Stratus Pharmaceuticals Inc, 12379 SW 130th Street, Miami, Florida 33186

Rx only

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box