Label: ANTIBACTERIAL BEAUTY- 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 1, 2010

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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, cocamidopropyl betaine, fragrance, sodium chloride, sodium cocoyl isethionate, sodium palmitate, sodium palm kernelate, stearic acid, tetrasodium EDTA, titanium dioxide, triclocarban, trisodium etidronate, water

  • Package label

    Pure Beauty Antibacterial Whiteimage description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BEAUTY 
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0017
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRICLOCARBAN (UNII: BGG1Y1ED0Y)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0017-33 in 1 CELLO PACK
    1100 g in 1 BOX
    2NDC:67510-0017-22 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)