Label: U-MAX MULTI BB- allantoin cream

  • 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 June 4, 2012

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  • ACTIVE INGREDIENT

    active ingredient: allantoin
  • INACTIVE INGREDIENT

    inactive ingredient:  macadamia ternifolia seed oil, simmondsia chinensis seed oil, cetyl ethylhexanoate, sorbitan sesquioleate, cetyl PEG/PPG10/1 dimethicone, ethylhexyl methoxycinnamate, hydrolyzed ellastin, butyl methoxydibenzoylmethane, shea butter, stearyl dimethicone, dimethicone, titanium dioxide, ci 77492, ci 77491, ci 44299, water, glycerin, butylene glycol, sodium chloride, hydrolyzed collagen, opuntia tuna fruit extract perform malt extract, houttuynia cordata extract, xanthium strumarium fruit extract, solanum lycopersicum fruit extract, clipta prostrata leaf extract, angelica gigas root extract, glycyrrhiza glabra root extract, camellia sinensis leaf extract, hydrolyzed soybean extract, artemisia vulgaris extract, laminaria japonica extract, taraxacum officinale leaf extract, citrus paradisi seed oil, musa sapientum fruit extract
  • PURPOSE

    skin protectant (BB)
  • 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 MULTI BB 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50795-2001
    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)  
    MACADAMIA NUT (UNII: Y5432RGW8N)  
    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)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BANANA (UNII: 4AJZ4765R9)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    TARAXACUM OFFICINALE (UNII: 39981FM375)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50795-2001-130 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