Label: ANTIBACTERIAL GOLD- triclocarban soap

  • 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 October 31, 2012

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  • Active Ingredient

    Triclocarban 0.10%

  • Purpose

    Antibacterial

  • Use

    For washing to decrease bacteria on the skin

  • Warnings

    For external use only

    • Avoid contact with eyes. In case of eye contact, flush with water.
    • Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet bar with water
    • Lather vigorously and wash skin
    • Rinse and dry thoroghly
  • Inactive Ingredient

    BHT, DC yellow no.8, FDC red no.4, FDC yellow no.5, glycerin, palmitic acid, PEG-6 methyl ether, pentasodium pentetate, sodium chloride, sodium palmitate, sodium palm kernelate, sorbitol, tetrasodium etidronate, water

  • Package label

    Pure Antibacterialimage of package label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL GOLD 
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 8 (UNII: 93X55PE38X)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PEG-6 METHYL ETHER (UNII: WXH089JZ5E)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SORBITOL (UNII: 506T60A25R)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0016-33 in 1 CELLO PACK
    1100 g in 1 BOX
    2NDC:67510-0016-22 in 1 CELLO PACK
    2100 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/07/2011
    Labeler - Kareway Product, Inc. (121840057)
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