Label: DARK SPOT CORRECTOR- polyethylene glycol 400 cream

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 18, 2012

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  • ACTIVE INGREDIENT

    Key Active Ingredients Seaweed, Licorice Root  Pearl Protein Extracts
  • 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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.
  • INDICATIONS & USAGE

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

    15ML. 051 FL OZ.
  • 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
  • PRINCIPAL DISPLAY PANEL

    label
    LANGE PARIS
    Dark Spot Corrector
    Concentrate with Seaweed extract and whitening complex
  • INGREDIENTS AND APPEARANCE
    DARK SPOT CORRECTOR 
    polyethylene glycol 400 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51830-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400.3 mg  in 15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51830-023-0315 mg in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/17/2012
    Labeler - LANGE SAS (275956105)
    Registrant - LANGE SAS (275956105)
    Establishment
    NameAddressID/FEIBusiness Operations
    LANGE SAS275956105manufacture(51830-023)