Label: U-MAX WHITENING FUNCTIONAL ESSENCE- allantoin cream

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

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Drug Label Information

Updated June 4, 2012

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  • ACTIVE INGREDIENT

    active ingredient: allantoin
  • INACTIVE INGREDIENT

    inactive ingredient: water, glycerin, propylene glycol, arbutin, disodium EDTA, tocopheryl acetate, carbomer, caprylic triglyceride, petrolatum, stearic acid, cetearyl alcohol, glyceryl stearate, sorbitan stearate, houttuynia cordata extract, saururus chinensis extract, xanthium strumarium fruit extract, solanum lycopersicum fruit extract, eclipta prostrata leaf extract, angelica gigas root extract, glycyrrhiza glabra root extract, camellia sinensis leaf extract, hydrolyzed soybean extract, artemisia vulgaris extract, perfume, portulaca oleracea extract, salicornia herbacea extract, laminaria japonica extract, taraxacum officinale leaf extract, morus bombycis leaf extract, poria cocos extract, eucommia ulmoides leaf extract, citrus paradisi seed oil, ubiquinone, biosaccharide gum-1, hydroxypropyl methylcellulose, iron titanium oxide, cellulose
  • PURPOSE

    skin whitening
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    - apply only for skin
    - apply 2 or 3 times a day with 5~6ml
    - massage with your finger over 2 min and let them dry


  • WARNINGS

    - keep out of eyes, ears and mouth
    - if contact occurs, rinse away with plenty of cold water
  • DOSAGE & ADMINISTRATION

    - for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    U-MAX WHITENING FUNCTIONAL ESSENCE 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50795-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)  
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L)  
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    ARBUTIN (UNII: C5INA23HXF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50795-3001-1120 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/04/2012
    Labeler - VS Shinbi Co., Ltd. (557817055)
    Registrant - VS Shinbi Co., Ltd. (557817055)
    Establishment
    NameAddressID/FEIBusiness Operations
    VS Shinbi Co., Ltd.557817055manufacture
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