Label: DERMACLAIR SKIN LIGHTENING - hydroquinone gel

  • NDC Code(s): 66129-134-31
  • Packager: International Beauty Exchange
  • 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 06/11

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

  • ACTIVE INGREDIENT

    Hydroquinone 2%

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  • WARNINGS

    For external use only

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  • DO NOT USE

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

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  • WHEN USING

    Avoid contact with eyes.

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  • PURPOSE

    Skin Lightener

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  • INDICATIONS & USAGE

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

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  • DOSAGE & ADMINISTRATION

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

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

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  • INACTIVE INGREDIENT

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

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  • INGREDIENTS AND APPEARANCE
    DERMACLAIR SKIN LIGHTENING 
    hydroquinone gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66129-134
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 1 g  in 50 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    GLYCERIN  
    CARBOMER COPOLYMER TYPE A  
    TROLAMINE  
    SODIUM METABISULFITE  
    EDETATE DISODIUM  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66129-134-31 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 01/01/2011
    Labeler - International Beauty Exchange (966261273)
    Establishment
    Name Address ID/FEI Business Operations
    JABONES PARDO SA 462018250 manufacture
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