Label: ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION- arbutin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 29, 2010

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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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