NDC Code(s) : 45802-980-64
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HydroquinoneHydroquinone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-980
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
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MINERAL OIL(UNII: T5L8T28FGP)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SQUALANE(UNII: GW89575KF9)
STEARIC ACID(UNII: 4ELV7Z65AP)
PEG-25 PROPYLENE GLYCOL STEARATE(UNII: X21KPH4633)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-980-641 in 1 CARTON 17/06/2008
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 06/17/2008 11/21/2018

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 45802-980-64

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

Hydroquinone USP, 4% Carton Image 1

Hydroquinone USP, 4% Carton Image 1

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 45802-980-64

Hydroquinone USP, 4%

Skin Bleaching Cream

Net Wt 1 oz (28.35 g)

Hydroquinone USP, 4% Tube