Label: PERSONAL CARE ANTIBACTERIAL- triclocarben 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 January 11, 2012

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  • ACTIVE INGREDIENT



    Active ingredient               Purpose

    Triclocarban .78%              Antibacterial

  • ASK DOCTOR



    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN



    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

  • PURPOSE



    Purpose   Antibacterial

  • WHEN USING



    When using this product avoid contact eyes. In case of eye contact, flush with plenty of water.

  • STOP USE



    Stop use and ask a doctor if irritation or redness develops.

  • DOSAGE & ADMINISTRATION



    Directions

    • Wet bar with water
    • lather vigorously and wash skin
    • rinse and dry thoroughly
  • INDICATIONS & USAGE



    Uses for washing to decrease bacteria on the skin.

  • INACTIVE INGREDIENT



    Inactive ingredients  sodium tallowate, sodium cocoate, sodium palm kernalate, sodium palmitate, cocnut acid, glycerin, sodium chloride, sorbitol, water(aqua), fragrance, titanium dioxide, BHT, disodium EDTA,

  • WARNINGS



    warnings For external use only

  • PRINCIPAL DISPLAY PANEL

    label


    Personal Care

    Antibacterial Soap

    Long lasting Deodorant protection

    2 bars

    3 oz (86 g)ea (Total net wt 6 oz)

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE ANTIBACTERIAL  
    triclocarben soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN.67 g  in 86 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    COCONUT ACID (UNII: 40U37V505D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9208-086 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2011
    Labeler - Personal Care Products LLC (966155082)
    Registrant - Personal Care Products LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Prodcuts Co Ltd528196956manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Soap Co Ltd545258233manufacture
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