Label: SOORYEHAN PURE-WHITENING ESSENCE- polydatin cream

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

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Drug Label Information

Updated May 14, 2010

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  • ACTIVE INGREDIENT

    POLYDATIN  0.22mL/100mL

  • WARNINGS AND PRECAUTIONS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.
  • STOP USE

    Stop use if a rash or irritation develops and lasts.
  • PRINCIPAL DISPLAY PANEL

    Sooryehan

    Essence

  • INGREDIENTS AND APPEARANCE
    SOORYEHAN PURE-WHITENING ESSENCE 
    polydatin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYDATIN (UNII: XM261C37CQ) (POLYDATIN - UNII:XM261C37CQ) POLYDATIN0.22   in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-442-021 in 1 BOX
    1NDC:53208-442-0145 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/14/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture
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