Label: ISA KNOX WHITE SYMPHONY AMPULE ESSENCE- atractylodes japonica root 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 May 24, 2010

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  • ACTIVE INGREDIENT

    ATRACTYLODES JAPONICA ROOT 0.525ml/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.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • PRINCIPAL DISPLAY PANEL

    ISAKNOX

    WHITE SYMPHONY

    AMPULE ESSENCE

    AMPULE ESSENCE

  • INGREDIENTS AND APPEARANCE
    ISA KNOX WHITE SYMPHONY AMPULE ESSENCE 
    atractylodes japonica root cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) (ATRACTYLODES JAPONICA ROOT - UNII:58N5X5H9XU) ATRACTYLODES JAPONICA ROOT0.0525 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    2-ETHYLHEXANOIC ACID (UNII: 01MU2J7VVZ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRIC ACID (UNII: 4G9EDB6V73)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BETAINE (UNII: 3SCV180C9W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-414-021 in 1 BOX
    1NDC:53208-414-0150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture