Label: GONGJINHYANG SEOL WHITENING- atractylodes japonica root oil 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 March 15, 2011

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  • ACTIVE INGREDIENT

    ATRACTYLODES JAPONICA ROOT OIL 0.05%

  • WARNINGS

    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.

  • PURPOSE

    Whitening functional cosmetic.

  • INDICATIONS & USAGE

    The last step in basic skin care, dispense pea-sized amount and apply the cream.

  • INACTIVE INGREDIENT

    WATER, DIPROPYLENE GLYCOL, GLYCERIN, CYCLOMETHICONE 5, ALCOHOL, PANTHENOL, MEDIUM-CHAIN TRIGLYCERIDES, 1,2-HEXANEDIOL, TEA LEAF, POLYETHYLENE GLYCOL 6000, TROMETHAMINE, EDETATE TRISODIUM.

  • DOSAGE & ADMINISTRATION

    Use as the last step of skin care.

  • PRINCIPAL DISPLAY PANEL

    The History of Whoo Gongjinhyang: Seol Whitening Cream

    Seol Cream Renewed

  • INGREDIENTS AND APPEARANCE
    GONGJINHYANG SEOL WHITENING 
    atractylodes japonica root oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATRACTYLODES JAPONICA ROOT OIL (UNII: EC228KGY00) (ATRACTYLODES JAPONICA ROOT OIL - UNII:EC228KGY00) ATRACTYLODES JAPONICA ROOT OIL0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TEA LEAF (UNII: GH42T47V24)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-504-021 in 1 BOX
    1NDC:53208-504-0150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/15/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture