Label: O HUI WHITE EXTREME CELLIGHT- protocatechualdehyde emulsion

  • 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 14, 2012

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  • ACTIVE INGREDIENT

    PROTOCATECHUALDEHYDE 0.0315%
  • PURPOSE

    Whitening Emulsion

  • 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, GLYCERIN, DIPROPYLENE GLYCOL, MEDIUM-CHAIN TRIGLYCERIDES, TRIETHYLHEXANOIN, HYDROGENATED POLYDECENE, CYCLOPENTASILOXANE, BETAINE, BIOSACCHARIDE GUM-1, ALCOHOL, GLYCERYL MONOSTEARATE, FRUIT, YELLOW WAX, STEARIC ACID, PANTHENOL, COPPER  TRIPEPTIDE-1, METHYLPARABEN, PROPYLPARABEN,  ETHYLPARABEN, XANTHAN GUM, SODIUM METABISULFITE, TRISODIUM EDTA, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    OHUI

    WHITE EXTREME

    CELLIGHT EMULSION

    White Extreme EMulsion

  • DOSAGE & ADMINISTRATION

    Use as needed to whiten skin.

  • INGREDIENTS AND APPEARANCE
    O HUI WHITE EXTREME CELLIGHT 
    protocatechualdehyde emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROTOCATECHUALDEHYDE (UNII: 4PVP2HCH4T) (PROTOCATECHUALDEHYDE - UNII:4PVP2HCH4T) PROTOCATECHUALDEHYDE0.0315 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FRUIT (UNII: C2AIY4ERZC)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BETAINE (UNII: 3SCV180C9W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    COPPER (UNII: 789U1901C5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-501-021 in 1 BOX
    1NDC:53208-501-01150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/07/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture