NU-DERM CLEAR Skin Bleaching and Corrector (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 57 g Bottle Label — 6

OBAGI

NU-DERM®
NDC 62032-116-36

AM
6

SUNFADER®
HYDROQUINONE USP, 4%

SKIN LIGHTENER
WITH SUNSCREEN(SPF 15) PABA-FREE

Rx only

Net wt. 2 oz. (57 g)

PRINCIPAL DISPLAY PANEL -- 57 g Bottle Label -- 6
(click image for full-size original)
NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
GLYCERIN
SODIUM LAURYL SULFATE
STEARYL ALCOHOL
LACTIC ACID, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
EDETATE DISODIUM
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
BUTYLPARABEN
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-101-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
NU-DERM BLENDER SKIN LIGHTENER AND BLENDING hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CETYL ALCOHOL
PPG-2 MYRISTYL ETHER PROPIONATE
SODIUM LAURYL SULFATE
TROLAMINE SALICYLATE
LACTIC ACID, UNSPECIFIED FORM
PHENYL TRIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
SODIUM METABISULFITE
ASCORBIC ACID
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-100-10 28 g in 1 BOTTLE, PLASTIC None
2 NDC:62032-100-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
NU-DERM SUNFADER SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA FREE hydroquinone, octinoxate, and oxybenzone lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 55 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
GLYCERIN
SODIUM LAURYL SULFATE
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
EDETATE DISODIUM
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
BUTYLPARABEN
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-116-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1984
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 MANUFACTURE (62032-101), MANUFACTURE (62032-100), MANUFACTURE (62032-116), LABEL (62032-101), LABEL (62032-100), LABEL (62032-116), PACK (62032-101), PACK (62032-100), PACK (62032-116)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (62032-101), MANUFACTURE (62032-100)

Revised: 11/2019 Obagi Cosmeceuticals LLC

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