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]

  • 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

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NU-DERM SYSTEM NORMAL-DRY  SKIN TRANSFORMATION TRIAL
    hydroquinone, octinoxate,and zinc oxide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62032-522
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62032-522-601 in 1 CARTON04/15/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 28 g
    Part 21 BOTTLE, PLASTIC 28 g
    Part 31 TUBE 28 g
    Part 41 BOTTLE, PLASTIC 59 mL
    Part 51 BOTTLE, PLASTIC 59 mL
    Part 61 BOTTLE, PLASTIC 28 g
    Part 1 of 6
    NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
    hydroquinone cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/1988
    Part 2 of 6
    NU-DERM CLEAR   SKIN BLEACHING AND CORRECTOR
    hydroquinone cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/1988
    Part 3 of 6
    NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
    octinoxate and zinc oxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/21/2013
    Part 4 of 6
    NU-DERM GENTLE CLEANSER 
    cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRCARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/1988
    Part 5 of 6
    NU-DERM TONER 
    face and neck (excluding shaving preparations) liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSAGE (UNII: 065C5D077J)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/1988
    Part 6 of 6
    NU-DERM EXFODERM 
    face and neck (excluding shaving preparations) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRCANOLA OIL (UNII: 331KBJ17RK)  
    INGRISOHEXADECANE (UNII: 918X1OUF1E)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRFYTIC ACID (UNII: 7IGF0S7R8I)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    INGRPOTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/15/2013
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bay Cities Container Corporation066229618RELABEL(62032-522) , REPACK(62032-522)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-522) , LABEL(62032-522) , PACK(62032-522)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-522)

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