ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]

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ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION (ARBUTIN) LOTION [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-385-01, 53208-385-02
Set ID 7ced5492-9ef6-4c0b-b040-d5dae08e4501
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART358
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  • ACTIVE INGREDIENT

    ARBUTIN 2.10g/100g

  • 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.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL

    BRIGHTENINGEMULSION
  • INGREDIENTS AND APPEARANCE
    ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION 
    arbutin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-385
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN2.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRIC ACID (UNII: 4G9EDB6V73)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    2-ETHYLHEXANOIC ACID (UNII: 01MU2J7VVZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BETAINE (UNII: 3SCV180C9W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CARBOMER 934 (UNII: Z135WT9208)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-385-021 in 1 BOX
    1NDC:53208-385-01120 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35803/29/2010
    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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