Label: ISAKNOX TERVINA LUMIERE WHITE- methyl undecenoyl leucinate cream

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

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Drug Label Information

Updated May 15, 2012

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  • ACTIVE INGREDIENT

    METHYL UNDECENOYL LEUCINATE 0.1%

  • PURPOSE

    Whitening cream

  • WARNINGS

    Stop use if rash or irritation develops and lasts.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove

  • INDICATIONS & USAGE

    Use to whiten skin.

  • 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.

  • INACTIVE INGREDIENT


    WATER
    BUTYLENE GLYCOL
    CYCLOMETHICONE 5
    GLYCERIN
    BIOSACCHARIDE GUM-1
    MEDIUM-CHAIN TRIGLYCERIDES
    NEOPENTYL GLYCOL DICAPRATE
    TREHALOSE
    DIMETHICONE
    PHENOXYETHANOL
    METHYLPARABEN
    ETHYLPARABEN
    BUTYLPARABEN
    PROPYLPARABEN
    ISOBUTYLPARABEN
    C14-22 ALCOHOLS
    C12-20 ALKYL GLUCOSIDE
    GLYCERYL MONOSTEARATE
    PEG-100 STEARATE
    SQUALANE
    CETEARYL OLIVATE
    SORBITAN OLIVATE
    HYALURONATE SODIUM
    1,2-HEXANEDIOL
    TROMETHAMINE
    EDETATE TRISODIUM

  • PRINCIPAL DISPLAY PANEL

    ISAKNOX TERVINA LUMIERE WHITE CREAM

  • DOSAGE & ADMINISTRATION

    Apply after the Eyecream

  • INGREDIENTS AND APPEARANCE
    ISAKNOX TERVINA LUMIERE WHITE 
    methyl undecenoyl leucinate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-530
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL UNDECENOYL LEUCINATE (UNII: D7PH6N3IEI) (METHYL UNDECENOYL LEUCINATE - UNII:D7PH6N3IEI) METHYL UNDECENOYL LEUCINATE0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
    TREHALOSE (UNII: B8WCK70T7I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SQUALANE (UNII: GW89575KF9)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-530-021 in 1 BOX
    1NDC:53208-530-0160 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/25/2011
    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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