Label: GLYCOLIC ACID cream

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

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Drug Label Information

Updated April 19, 2021

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

  • ACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    1.7 OZ

  • INGREDIENTS AND APPEARANCE
    GLYCOLIC ACID 
    glycolic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID1.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CITRAL (UNII: T7EU0O9VPP)  
    COUMARIN (UNII: A4VZ22K1WT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-114-1748 g in 1 BOTTLE; Type 0: Not a Combination Product04/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/07/2021
    Labeler - CHEMCO CORPORATION (032495954)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(49283-114)
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