Label: ACTIVATOR LIGHT- hydroquinone lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 6, 2013

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  • Active Ingredient


    Hydroquinone USP (2%)

  • Indication

    Skin Lightening

  • Indication

    To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation that can occur as a result of pregnancy or the use of oral contraceptives.

  • Precautions

    For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Use only on the advice of a physician. Contains Sodium Metabisulfite. See package insert for complete details.

  • Precautions

    keep out of reach of children

  • Directions

    Use fingertips to apply a thin layer to affected areas. Use at night or as directed by a physician. Gradual lightening of the discolored area can be expected in most cases. Close cap securely after each use. Store at room temperature (15-30°C / 59-86°F).

  • Non-Medicinal Ingredients

    Butylated Hydroxy Toluene, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance/Parfum, Glycerin, Lactic Acid, L-Ascorbic Acid USP, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Triethanolamine Salicylate, Water/Eau.

  • Principal Display Panel

    ActivatorLight_PackageLabel_PrincipalDisplayPanel

  • INGREDIENTS AND APPEARANCE
    ACTIVATOR LIGHT 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2720-61 in 1 BOX
    160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A09/01/2013
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivier Pharma, Inc.250996550manufacture(67226-2720)
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