NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL- hydroquinone, octinoxate,and zinc oxide kit

nu-derm system normal-dry by

Drug Labeling and Warnings

nu-derm system normal-dry by is a Prescription medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Bay Cities Container Corporation, PURETEK CORPORATION, G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Clear (Skin Bleaching and Corrector Cream) NDC:

62032-101-36 Net wt. 2 oz. (57 g) Hydroquinone USP, 4% Rx Only AM+PM

Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-size amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

DESCRIPTION

Each gram of Obagi Nu-Derm Clear contains:

Active ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients

water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben

SPL UNCLASSIFIED SECTION

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Blender® (Skin Lightener and Blending Cream) NDC:

62032-100-10 Net wt. 1 oz. (28 g) Hydroquinone USP, 4% Rx Only PM

A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream1 or Refissa®2 as prescribed by a physician.

1 Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.

2 Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.

Dosage and administration

Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-size drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

DESCRIPTION

Each gram of Obagi Nu-Derm Blender contains:

Active ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients

water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

SPL UNCLASSIFIED SECTION

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Travel Bag and Patient Instruction Guide

STORAGE AND HANDLING

Store at controlled room temperature 15°C–25°C (59°F–77°F).

SPL UNCLASSIFIED SECTION

Blender, Exfoderm, Nu-Derm, and the Obagi logo are registered trademarks of OMP, Inc.

Refissa is a registered trademark of Spear Pharmaceuticals, Inc.
Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All rights reserved.
obagi.com Made in USA 40706311Z 7063

Sun Shield Broad Spectrum SPF 50 Matte Net wt. 1 oz. (28 g)

This sunscreen combines UVB absorption and UVA protection in an elegant matte finish that is non-comedogenic, hypoallergenic, non-acnegenic, and dermatologist tested. Sheer, PABA free,

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Zinc Oxide 10.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

1,2 hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone, dimethicone crosspolymer-3, disodium EDTA, glycerin, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-40 stearate, pentylene glycol, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Other information

• store at controlled room temperature: 15°C–25°C (59°F–77°F)
• protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546
Monday–Friday 9 a.m.–4 p.m. Pacific Time

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC# 62032-522-60

OBAGI®
MEDICAL

NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Trial Kit

INGREDIENTS AND APPEARANCE

NU-DERM SYSTEM NORMAL-DRY  SKIN TRANSFORMATION TRIAL
hydroquinone, octinoxate,and zinc oxide kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62032-522

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-522-60	1 in 1 CARTON	04/15/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	28 g
Part 2	1 BOTTLE, PLASTIC	28 g
Part 3	1 TUBE	28 g
Part 4	1 BOTTLE, PLASTIC	59 mL
Part 5	1 BOTTLE, PLASTIC	59 mL
Part 6	1 BOTTLE, PLASTIC	28 g

Part 1 of 6

NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
hydroquinone cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/1988

Part 2 of 6

NU-DERM CLEAR   SKIN BLEACHING AND CORRECTOR
hydroquinone cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/1988

Part 3 of 6

NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
octinoxate and zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PEG-40 STEARATE (UNII: ECU18C66Q7)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROPOLONE (UNII: 7L6DL16P1T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 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
OTC monograph final	part352	02/21/2013

Part 4 of 6

NU-DERM GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	SAGE (UNII: 065C5D077J)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/1988

Part 5 of 6

NU-DERM TONER 
face and neck (excluding shaving preparations) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	POTASSIUM ALUM (UNII: 1L24V9R23S)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SAGE (UNII: 065C5D077J)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/1988

Part 6 of 6

NU-DERM EXFODERM 
face and neck (excluding shaving preparations) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	CANOLA OIL (UNII: 331KBJ17RK)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	FYTIC ACID (UNII: 7IGF0S7R8I)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PEG-150 STEARATE (UNII: 7BSG7DF10Q)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/15/2013

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Bay Cities Container Corporation		066229618	RELABEL(62032-522) , REPACK(62032-522)

Establishment
Name	Address	ID/FEI	Business Operations
PURETEK CORPORATION		785961046	MANUFACTURE(62032-522) , LABEL(62032-522) , PACK(62032-522)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(62032-522)