Label: METASOL- hydroquinone gel

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

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 July 14, 2011

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  • ACTIVE INGREDIENT

    Hydroquinone 2%

  • WARNINGS

    For external use only

  • DO NOT USE

    On children under 12 years of age unless directed by a doctor

  • WHEN USING

    Avoid contact with eyes.

  • PURPOSE

    Skin Lightener

  • INDICATIONS & USAGE

    For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots

  • DOSAGE & ADMINISTRATION

    Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    WATER, ALCOHOL, GLYCERIN, CARBOMER COPOLYMER TYPE A, TROLAMINE, SODIUM METABISULFITE, EDETATE DISODIUM, OENOTHERA BIENNIS

  • PRINCIPAL DISPLAY PANEL

    image of product

  • INGREDIENTS AND APPEARANCE
    METASOL 
    hydroquinone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66129-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1 g  in 50 g
    BENZOPHENONE (UNII: 701M4TTV9O) (BENZOPHENONE - UNII:701M4TTV9O) BENZOPHENONE.05 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OENOTHERA BIENNIS (UNII: 76UI55V071)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66129-540-3150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/01/2011
    Labeler - International Beauty Exchange (966261273)
    Establishment
    NameAddressID/FEIBusiness Operations
    JABONES PARDO SA462018250manufacture
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