NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION (Page 2 of 2)

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PRINCIPAL DISPLAY PANEL — Kit Carton

NDC# 62032-520-00

OBAGI ®
MEDICAL

NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Kit

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
NU-DERM GENTLE CLEANSER Cleansing (cold creams, cleansing lotions, liquids, and pads)
NU-DERM TONER Face and Neck (excluding shaving preparations)
NU-DERM EXFODERM Face and Neck (excluding shaving preparations)
NU-DERM HYDRATE FACIAL MOISTURIZER Face and Neck (excluding shaving preparations)
NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION
hydroquinone, octinoxate, and zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-520
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-520-00 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 57 g
Part 2 1 BOTTLE, PLASTIC 57 g
Part 3 1 TUBE 85 g
Part 4 1 BOTTLE, PLASTIC 198 mL
Part 5 1 BOTTLE, PLASTIC 198 mL
Part 6 1 BOTTLE, PLASTIC 57 g
Part 7 1 BOTTLE, PLASTIC 48 g
Part 1 of 7
NU-DERM BLENDER SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
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
EDETATE DISODIUM
PPG-2 MYRISTYL ETHER PROPIONATE
TROLAMINE SALICYLATE
SODIUM LAURYL SULFATE
CETYL ALCOHOL
GLYCERIN
LACTIC ACID
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
WATER
METHYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
PHENYL TRIMETHICONE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 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
Part 2 of 7
NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
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
EDETATE DISODIUM
BUTYLPARABEN
STEARYL ALCOHOL
SODIUM LAURYL SULFATE
CETYL ALCOHOL
GLYCERIN
LACTIC ACID
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
WATER
METHYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
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
Part 3 of 7
NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Item Code (Source) NDC:62032-126
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 105 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5
WATER
GLYCERIN
PHENOXYETHANOL
XANTHAN GUM
CHLORPHENESIN
PENTYLENE GLYCOL
PHENYL TRIMETHICONE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
SQUALANE
POLYSORBATE 60
PEG-40 STEARATE
DIMETHICONE
STEARYL ALCOHOL
CETOSTEARYL ALCOHOL
SODIUM DIHYDROXYCETYL PHOSPHATE
HYDROGENATED PALM GLYCERIDES
POLYOXYL 20 CETOSTEARYL ETHER
CITRIC ACID MONOHYDRATE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
TROPOLONE
EDETATE DISODIUM
POTASSIUM SORBATE
SODIUM BENZOATE
METHYLISOTHIAZOLINONE
TETRAHEXYLDECYL ASCORBATE
SODIUM POLYACRYLATE (2500000 MW)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-126-90 85 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/21/2013
Part 4 of 7
NU-DERM GENTLE CLEANSER
inert liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
PHENOXYETHANOL
METHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
ISOBUTYLPARABEN
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM LAUROYL OAT AMINO ACIDS
COCAMIDOPROPYL BETAINE
SODIUM LAURETH-3 SULFATE
ALOE VERA LEAF
GLYCERETH-7
PANTHENOL
DIETHYLENE GLYCOL MONOETHYL ETHER
TROLAMINE
SAGE
FD&C YELLOW NO. 5
APRICOT KERNEL OIL
Product Characteristics
Color YELLOW Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 198 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Part 5 of 7
NU-DERM TONER
inert liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
HAMAMELIS VIRGINIANA TOP WATER
SODIUM PYRROLIDONE CARBOXYLATE
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
POTASSIUM ALUM
PANTHENOL
SAGE
CALENDULA OFFICINALIS FLOWER
POLYSORBATE 80
ALLANTOIN
ALOE VERA LEAF
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 198 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Part 6 of 7
NU-DERM EXFODERM
inert lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
DIETHYLENE GLYCOL MONOETHYL ETHER
METHYLPARABEN
PROPYLPARABEN
POLYSORBATE 60
CETOSTEARYL ALCOHOL
STEARETH-20
CANOLA OIL
ISOHEXADECANE
MAGNESIUM ALUMINUM SILICATE
CETYL ALCOHOL
FYTIC ACID
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
DIMETHICONE
PEG-150 STEARATE
PHENOXYETHANOL
BUTYLPARABEN
ETHYLPARABEN
ISOBUTYLPARABEN
POTASSIUM CETYL PHOSPHATE
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE
GLYCERETH-7
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/01/1988
Part 7 of 7
NU-DERM HYDRATE FACIAL MOISTURIZER
inert lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
SODIUM HYDROXIDE
CAESALPINIA SPINOSA RESIN
SHEA BUTTER
GLYCERYL MONOSTEARATE
CYCLOMETHICONE 5
CETYL ALCOHOL
SACCHARIDE ISOMERATE
DIMETHICONE
TOCOPHEROL
LAURETH-12
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
STEARIC ACID
AVOCADO OIL
SOY STEROL
CAPRYLYL GLYCOL
LEVOMENOL
HEXYLENE GLYCOL
TETRAHYDRODIFERULOYLMETHANE
PANTHENOL
MANGIFERA INDICA SEED BUTTER
SODIUM STEAROYL GLUTAMATE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALLANTOIN
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 48 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/15/2013
Labeler — OMP, INC. (790553353)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL (62032-520), REPACK (62032-520)
Establishment
Name Address ID/FEI Operations
PURETEK CORPORATION 785961046 MANUFACTURE (62032-520), LABEL (62032-520), PACK (62032-520)
Establishment
Name Address ID/FEI Operations
Ei INC. 105803274 MANUFACTURE (62032-520), LABEL (62032-520), PACK (62032-520), ANALYSIS (62032-520)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (62032-520)

Revised: 08/2013 OMP, INC.

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