Label: DARK SPOT CORRECTOR- polyethylene glycol 400 cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/12

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  • ACTIVE INGREDIENT

    Key Active Ingredients Seaweed, Licorice Root  Pearl Protein Extracts Close
  • PURPOSE

    Dark Spot Corrector Lange
    A remarquable formula highly concentrated in whitening actives for an intensive treatment through local applications on dark spots. Its efficient corrective functions on pigment irregularities will help to:
    • Eliminate melanin synthesis at all levels on Dark Sports,
    • Actively prevent the appearance of new dark spots,
    • Create a more even appearance.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.
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  • INDICATIONS & USAGE

    This Whitening Seaweed inhibits melanine synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.
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  • WARNINGS

    WARNING!
    Avoid contact with the eyes; avoid or afford protecting UV whilst using products containing AHA because of the suggestion of susceptibility to increased damage from UV.
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  • DOSAGE & ADMINISTRATION

    15ML. 051 FL OZ.
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  • INACTIVE INGREDIENT

    WATER, PEG-8, POLYSORBATE 20, MANNITOL, CHONDRUS CRISPUS (CARRAGEENAN) PLANTS AND PLANT EXTRACTS, PROPYLENE GLYCOL, GLYCERIN DENATURANT, PHENOXYETHANOL, BENZOPHENONE-4, SODIUM METHYLPARABEN, BENZYL ALCOHOL PRESERVATIVE, SODIUM PCA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, DISODIUM EDTA CHELATING, SODIUM GLUCONATE CHELATING, MAGNESIUM ASCORBYL PHOSPHATE, CITRIC ACID, SODIUM CITRATE, CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT, ASCOPHYLLUM NODOSUM EXTRACT, SODIUM PROPYLPARABEN, BUTYLENE GLYCOL HUMECTANT, WALTHERIA INDICA LEAF EXTRACT,TITANIUM DIOXIDE, BAMBUSA VULGARIS LEAF, DEXTRIN ABSORBENT, FERULIC ACID, METHYLPARABEN PRESERVATIVE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, MALIC ACID, PROPYLPARABEN, HYDROLYZED CONCHIOLIN PROTEIN, TARTARIC ACID, FREESIA ALBA FLOWER EXTRACT, GARDENIA TAHITENSIS FLOWER EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT Close
  • PRINCIPAL DISPLAY PANEL

    label
    LANGE PARIS
    Dark Spot Corrector
    Concentrate with Seaweed extract and whitening complex Close
  • INGREDIENTS AND APPEARANCE
    DARK SPOT CORRECTOR 
    polyethylene glycol 400 cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-023
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 .3 mg  in 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MANNITOL (UNII: 3OWL53L36A)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TANGERINE (UNII: KH3E3096OO)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WALTHERIA INDICA LEAF (UNII: T69OLD6617)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    FERULIC ACID (UNII: AVM951ZWST)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MALIC ACID (UNII: 817L1N4CKP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TARTARIC ACID (UNII: W4888I119H)  
    FREESIA ALBA FLOWER (UNII: 33X293N6JT)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51830-023-03 15 mg in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2012
    Labeler - LANGE SAS (275956105)
    Registrant - LANGE SAS (275956105)
    Establishment
    Name Address ID/FEI Business Operations
    LANGE SAS 275956105 manufacture(51830-023)
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