Label: SKIN LIGHTENING COMPLEX- hydroquinone cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 7, 2019

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  • USE

    HELPS LIGHTEN DARK PATCHES OF SKIN SUCH AS AGE SPOTS, MELASMA, FRECKLES AND HYPERPIGMENTATION THAT CAN OCCUR AS A RESULT OF PREGNANCY, USE OF ORAL CONTRACEPTIVES OR INJURY TO THE SKIN. RX ONLY. FOR EXTERNAL USE ONLY.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Skin Lightening Complex_HQ 4pct

    01b LBL_Skin Lightening Complex_HQ 4pct_Panel 101b LBL_Skin Lightening Complex_HQ 4pct_Panel 1

  • INGREDIENTS AND APPEARANCE
    SKIN LIGHTENING COMPLEX 
    hydroquinone cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70484-101
    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
    ARBUTIN (UNII: C5INA23HXF)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    KOJIC DIPALMITATE (UNII: 13N249RWTM)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70484-101-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/28/2019
    Labeler - Vi Medical Products Inc. (063910521)
    Registrant - Vi Medical Products Inc. INC (063910521)
    Establishment
    NameAddressID/FEIBusiness Operations
    MICRO CONNECTION ENTERPRISES INC144297160manufacture(70484-101)
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