Label: VIVANT TRUE TONE FORTE- hydroquinone gel

  • NDC Code(s): 63750-001-01
  • Packager: Vivant Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 6, 2024

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  • Active Ingredient

    Hydroquinone (2%)

  • Indication

    Skin Lightening

  • Uses

    Uses

    ■ For the gradual fading of age spots

    ■ Lightens dark pigment in the skin

    ■This product provides minimal SPF protection.

  • Warnings

    Warnings ■Sun exposure should be avoided indefinitely by using a high SPF sunscreen agent, a sunblocking agent, or protective clothing to cover bleached skin in order to prevent darkening from reoccurring ■ Do not get into eyes ■Keep out of reach of

    children ■For external use only ■Not recommended for children under 12 years of age ■ If swallowed get medical help or contact a poison control center immediately.

  • Ask a doctor if you are:

    using other topical acne medications

  • Directions

    Directions ■ Adult topical dosage is a thin layer to the affected area once or twicedaily■There is no recommended dosage for children under 12 years of age except under the advice and supervision of a doctor ■ Keep refrigerated

  • Inactive Ingredients

    Alcohol Denat, Ethoxydiglycol, Ethylhexyl Dimethyl PABA Hydroquinone USP, Kojic Acid USP, Citric Acid USP, Retinyl Propionate

    Propylene Glycol, Hydroxypropylcellulose

  • When using this product

    if not improvement is seen after 2 months of treatment, use of this products should be discontinued

  • Stop use and ask the doctor if

    excessive skin irritation develops or increases

  • Warnings

    Keep out of reach of children■For external only■Not recommended for children under12 years of age

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    VIVANT TRUE TONE FORTE 
    hydroquinone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PADIMATE O (UNII: Z11006CMUZ)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    RETINYL PROPIONATE (UNII: 32JK994WMC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 140000 MW) (UNII: 599BTP6K9F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63750-001-011 in 1 BOX02/01/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2024
    Labeler - Vivant Pharmaceuticals, LLC (782696814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivant Pharmaceuticals, LLC782696814manufacture(63750-001)
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