Label: HQ PLUS BRIGHTENING CREAM VI DERM- hydroquinone cream

  • 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 July 5, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient                    Purpose

    Hydroquinone 2.0%                 Skin Brightening

  • PURPOSE

    Use

    • Skin brightening formula that may help reduce discolorations
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop and ask a doctor if skin irritation becomes severe

  • WARNINGS

    Warning

    • For External Use only. When using this product: avoid unnecessary sun exposure and use a suncreen
    • Some Users of this product may experience a mild irritation
    • Do not use on children under 12 years of age, unless directed by a doctor
  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse the skin thoroughly before use. Cover the affected area with thin layer morning and night. Use Sunscreen daily. We recommend VI Derm SPF50+

  • INACTIVE INGREDIENT

    Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Isopropyl Palmitate, Butylene Glycol, Glycerin, PEG-100 Stearate, Cetearyl Alcohol, Azelaic Acid, Cetyl Phosphate, Triethanolamine, Arbutin, Fragrance, Kojic Acid, Rumex Occidentalis Extract, Ascorbic Acid, Dicetyl Phosphate, Ceteth-10 Phosphate, Sodium Ascorbyl Phosphate, Dimethicone, Bisabolol, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Metabisulfite, Zea Mays (Corn) Oil, BHT, Lactic Acid, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tetrasodium EDTA, Ethylhexylglycerin, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    VI Derm HQ Plus

    Brightening Cream

    1.75 FL OZ/50 mL

    Label

  • INGREDIENTS AND APPEARANCE
    HQ PLUS BRIGHTENING CREAM  VI DERM
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ARBUTIN (UNII: C5INA23HXF)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CORN OIL (UNII: 8470G57WFM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70484-003-021 in 1 BOX07/05/2016
    1NDC:70484-003-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A07/05/2016
    Labeler - Vi Medical Products Inc. (063910521)
    Registrant - VEGE-KURL, INC (021072509)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC 021072509manufacture(70484-003)
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