Label: ADVANCED SKIN LIGHTENING SERUM- hydroquinone liquid

  • 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 March 19, 2018

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  • Active Ingredient

    Hydroquinone 2% USP in a nonmedicinal liquid gel base containing Vitamin C IDS™ (L-Ascorbic Acid USP).

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  • Indication

    Skin Lightening

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  • Indication

    To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles, or other areas of unwanted melanin hyperpigmentation that may occur as a result of pregnancy or from the use of oral contraceptives.

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  • Precautions

    For external use only. Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water. Keep out of
    reach of children. Vitamin C (L-Ascorbic Acid USP) may cause a slight tingling sensation in some people. This is normal and will usually diminish with time. See package insert for more details.

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  • Precautions

    Keep out of reach of children.

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  • Directions

    Remove and discard white cap and replace with dropper. Place two to three drops in palm of hand and use fingertips to apply a thin layer
    to face, neck, chest and back of hands as desired. Use both morning and night or as directed by a physician. Close dropper cap securely after each use. Gradual lightening of the discoloration can be expected in most cases. L-Ascorbic Acid USP will tend to oxidize and change to a light yellow color with time. This change in color is natural and will not significantly alter the product’s effectiveness. Store at room temperature (15-25ºC / 59-77ºF).

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  • Non-Medicinal Ingredients

    CITRUS GRANDIS (GRAPEFRUIT) EXTRACT, ETHOXYDIGLYCOL, FRAGRANCE, L-ASCORBIC ACID USP, PROPYLENE GLYCOL, WATER/EAU.

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ADVANCED SKIN LIGHTENING SERUM 
    hydroquinone liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2621
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GRAPEFRUIT (UNII: O82C39RR8C)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67226-2621-3 1 in 1 BOX 09/30/2016 12/01/2018
    1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 09/30/2016 12/01/2018
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    Name Address ID/FEI Business Operations
    Entreprises ImportFAB Inc. 248586117 manufacture(67226-2621)
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