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

NU-DERM SYSTEM NORMAL-OILY by

Drug Labeling and Warnings

NU-DERM SYSTEM NORMAL-OILY by is a Prescription medication manufactured, distributed, or labeled by OMP, INC., MILBAR LABORATORIES, PURETEK CORPORATION, Ei INC., G.S. COSMECEUTICAL USA, INC., Bay Cities Container Corporation. 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-sized 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, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact 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.

    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 Insruction Guide

  • STORAGE AND HANDLING

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

  • STORAGE AND HANDLING

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

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

    ©2012 Obagi Medical Produts, Inc. All RIghts Reserved.
    OBAGI.COM Made in USA 41706410Z 7064

  • SPL UNCLASSIFIED SECTION

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

    This sunscreen combines UVB absorption and UVA protection in an elegant, matte finish that is non-comedogenic, allergy tested, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 7.5%Sunscreen
    Zinc Oxide 10.5%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 crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, 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# 62032-515-60

    OBAGI®
    MEDICAL

    NU-DERM® SYSTEM

    NORMAL OILY

    Skin Transformation Trial Kit

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    NU-DERM SYSTEM NORMAL-OILY  SKIN TRANSFORMATION TRIAL
    hydroquinone, octinoxate, and zinc oxide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62032-515
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62032-515-601 in 1 CARTON11/07/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 28 g
    Part 21 BOTTLE, PLASTIC 57 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
    157 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
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    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 finalpart35211/07/2012
    Part 4 of 6
    NU-DERM FOAMING 
    cleansing (cold creams, cleansing lotions, liquids, and pads) gel
    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)  
    INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRALFALFA (UNII: DJO934BRBD)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorREDScore    
    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)  
    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)  
    INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    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 FORTE 
    face and neck (excluding shaving preparations) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGREMU OIL (UNII: 344821WD61)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    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 other11/07/2012
    Labeler - Obagi Cosmeceuticals LLC (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    MILBAR LABORATORIES195556790MANUFACTURE(62032-515)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURETEK CORPORATION785961046MANUFACTURE(62032-515) , LABEL(62032-515) , PACK(62032-515)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-515)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bay Cities Container Corporation066229618RELABEL(62032-515) , REPACK(62032-515)

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