Label: VIVANT TRUE TONE- hydroquinone cream

  • NDC Code(s): 63750-002-01
  • Packager: Vivant Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 6, 2024

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

  • Active Ingredient

    Hydroquinone (2%)

  • Indication

    Skin Bleaching Agent

  • 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

    Inactive Ingredients• Water, Mineral Oil, Propylene Glycol, Glyceryl Stearate, PEG-10O Stearate, Vitis Vinifera (Grape Seed) Seed Oil, Cetyl Alcohol, Emulsifying Wax, Caprylic/Capric Triglyceride, Retinyl Propionate, Kojic Acid, EthylhexylDimethyl PABA, Dimethicone, HydrolyzedOat Protein, Aloe Barbadensis Leaf Juice, Polyacrylamide, C13-14 isoparaffin, Laureth-7, Xanthan Gum, Sodium Hydroxide, Sodium Metabisulfite, Sodium Bisullte, Phenoxyethanol, Ethylhexylglycerin

  • 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

  • Other Information

    Other Information• Depigmentation(lightening) effect of this product may not be noticeable when used on very dark skin

    This product will bleach skin and is not for the prevention of sunburn.

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    VIVANT TRUE TONE 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-002
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PADIMATE O (UNII: Z11006CMUZ)  
    VITIS VINIFERA LEAF OIL (UNII: 76K69S9H5Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    RETINYL PROPIONATE (UNII: 32JK994WMC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEG-60 STEARATE (UNII: 7TB32G765E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63750-002-011 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(63750-002)