Label: SEEQUIN 4- 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 November 7, 2013

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  • Active Ingredient

    Hydroquinone USP (4%)

  • Indication

    Skin Lightening

  • 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 in pregnancy or from the use of oral contraceptives.

  • Precautions

    For external use only. A mild transient stinging may occur for people with sesitive skin. Do not use onbroken or irritated skin. Discontinue use if irritation or rash occurs. Avoid contct with eyes and mucous membranes. In case of contact rinse thoroughly with water. Do not use on children under 12 years of age. Keep away from children. Avoid use around the eyes and lips.

  • Precautions

    Keep away from children.

  • Directions

    Remove and discard solid white cap from bottle and replace with dropper. To apply, place 1 to 2 drops of SEEQUIN™ 4 IDS ™ (Skin Lightening) Liquid Gel S-e rum* 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. Gradual lightening of the discoloration can be expected in most cases. Close dropper cap securely after each use. Store at room temperature (15-25ºC / 59-77ºF).

  • Non-Medicinal Ingredients

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

  • Principal Display Panel

    SEEQUIN 4_PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    SEEQUIN 4 
    hydroquinone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-1040
    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
    GRAPEFRUIT (UNII: O82C39RR8C)  
    DIETHYLENE GLYCOL MONOMETHYL ETHER (UNII: 465DDJ8G8K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-1040-31 in 1 BOX
    130 mL in 1 BOTTLE, DROPPER
    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(67226-1040)
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