LUMIPEARL DARK MARK CORRECTOR (HYDROQUINONE) CREAM [GUTHY-RENKER LLC]

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  • LUMIPEARL DARK MARK CORRECTOR (HYDROQUINONE) CREAM [GUTHY-RENKER LLC]

LUMIPEARL DARK MARK CORRECTOR (HYDROQUINONE) CREAM [GUTHY-RENKER LLC]
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NDC 70605-055-02, 70605-055-11
Set ID 404b3760-80db-4278-800d-dd7df48e746c
Category HUMAN OTC DRUG LABEL
Packager Guthy-Renker LLC
Generic Name
Product Class
Product Number
Application Number PART358A
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  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Use

    Works deep in the skin's surface to fade spots

  • Warnings

    For external use only

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen.
    • some users of this product may experience a mild skin irritation.
    • do not use on children under 12 years of age, unless directed by a doctor.

    Stop use and ask a doctor

    • skin irritation becomes severe or gradual darkening of the skin occurs.
    • if pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    • if swallowed, get medical help or contact a Poison Control Center right away.
    • Discontinue use if no improvement is seen after 3 months of treatment.
    • Avoid unnecessary sun exposure and use a sunscreen during the day of SPF 15 or higher.
  • Directions

    After cleansing the skin, apply a thin layer of product to age spots and dark spots.

  • Inactive ingredients

    water, octyldodecanol, cyclopentasiloxane, hexylene glycol, polyquaternium-37, glycolic acid, cyclohexasiloxane, cetearyl alcohol, propylene glycol dicaprylate/dicaprate, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, propylene glycol, glyceryl dilaurate, PPG-1 trideceth-6, glyceryl stearate, PEG-100 stearate, PEG-40 stearate, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance.

  • Questions or comments?

    Within US 1-888-920-7477

  • SPL UNCLASSIFIED SECTION

    Dist. by Guthy-Renker® LLC.
    100 N Sepulveda Blvd., El Segundo, CA 90245.

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Label

    LuMIPEARL™

    DARK MARK
    CORRECTOR

    1 FL. OZ. / 30mL

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    LUMIPEARL DARK MARK CORRECTOR 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Octyldodecanol (UNII: 461N1O614Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Glyceryl Dilaurate (UNII: MFL3ZIE8SK)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)  
    Sodium Sulfite (UNII: VTK01UQK3G)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Methylparaben (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    HEXAMETHYLCYCLOTRISILOXANE (UNII: EPV75L8O0R)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-055-1130 mL in 1 TUBE; Type 0: Not a Combination Product12/30/2017
    2NDC:70605-055-0210 mL in 1 TUBE; Type 0: Not a Combination Product12/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart358A12/30/2017
    Labeler - Guthy-Renker LLC (948861877)
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