Label: ADVANCED SKIN LIGHTENING SERUM- 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 December 27, 2017

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

  • Drug facts
  • Active ingredient

    Hydroquinone USP 2%

    Purpose

    Skin bleaching

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  • Use

    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 from the use of oral contraceptives.

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  • Warnings

    For external use only.
    Use only on the advice of a physician.

    Do not use

    • On broken or irritated skin.
    • On children under 12 years of age.
    • If you are pregnant, nursing or you intend to become pregnant within 3 months of use.

    Sunburn alert:Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin.

    When using this product

    • A mild transient stinging may occur for people with sensitive skin.
    • Gradual lightening of the discolored area can be expected in most cases.
    • Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water.

    Stop using this product

    if irritation or rash occurs.

    Keep out of reach of children.

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  • Directions

    • Remove and discard white cap and replace with dropper.
    • To apply, place 1 to 2 drops of ADVANCED SKIN LIGHTENING SERUM in palm of hand and use fingertips to apply a thin layer to affected areas.
    • Use both morning and night or as directed by a physician.
    • Close cap securely after each use.
    • Close dropper cap securely after each use.

    Information pharmaceutique (suite)

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  • Other information / Autres renseignements

    • See package insert for more details. / Voir l’info-feuillet pour plus de détails.
    • Store at room temperature (15-30°C / 59-86°F). / Conserver à la température ambiante (15-30 °C / 59-86 °F).

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  • Inactive ingredients

    Citrus Grandis (Grapefruit) Extract, Ethoxydiglycol, Fragrance, L-Ascorbic Acid USP, Propylene Glycol,
    Water/Eau.

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  • Questions?

    450 455 9779 1 877 484 8437

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    ADVANCED SKIN LIGHTENING SERUM 
    hydroquinone gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2622
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GRAPEFRUIT (UNII: O82C39RR8C)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67226-2622-3 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 11/06/2017
    Labeler - Vivier Pharma, Inc. (250996550)
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