Label: CLARITE 4- hydroquinone cream

  • 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 7, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient

    Hydroquinone USP (4%)

  • Indication

    Skin Bleaching and Correcting

  • 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. Use only on the advice of a physician. A mild transient stinging may occur for people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid usage around the eyes and lips.

  • Precautions

    Keep out of reach of children.

  • Directions

    Use fingertips to apply a thin layer to affected areas. Use both morning and 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, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA, Ethoxydiglycol, Fragrance/Parfum (Carubba C6929), 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, Water/Eau.

  • Principal Display Panel

    CLARITE 4_PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    CLARITE 4 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2040-61 in 1 BOX
    160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A05/30/2014
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivier Pharma, Inc.250996550manufacture(67226-2040)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!