Label: ACTIVATOR LIGHT- hydroquinone lotion 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 11/13

If you are a consumer or patient please visit this version.

  • Active Ingredient


    Hydroquinone USP (2%)

    Close
  • Indication

    Skin Lightening

    Close
  • 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.

    Close
  • 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.

    Close
  • Precautions

    keep out of reach of children

    Close
  • 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).

    Close
  • 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.

    Close
  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ACTIVATOR LIGHT 
    hydroquinone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67226-2720
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    CETOSTEARYL ALCOHOL  
    CETYL ALCOHOL  
    EDETATE DISODIUM  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    GLYCERIN  
    LACTIC ACID  
    ASCORBIC ACID  
    METHYLPARABEN  
    PHENYL TRIMETHICONE  
    PPG-2 MYRISTYL ETHER PROPIONATE  
    PROPYLPARABEN  
    SODIUM CETOSTEARYL SULFATE  
    SODIUM LAURYL SULFATE  
    SODIUM METABISULFITE  
    .ALPHA.-TOCOPHEROL ACETATE  
    TROLAMINE SALICYLATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67226-2720-6 1 in 1 BOX
    1 60 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 09/01/2013
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    Name Address ID/FEI Business Operations
    Vivier Pharma, Inc. 250996550 manufacture(67226-2720)
    Close