Label: ANTIBACTERIAL BAR- triclosan soap

  • Category: HUMAN OTC DRUG LABEL

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 9, 2012

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Triclosan 0.3%

  • Purpose

    Antibacterial

  • USES

    For washing to decrease bacteria on the skin.

  • WARNINGS

    For external use only.

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and ask 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.
    • Later vigorously and wash skin.
    • Rinse and dry thoroughly.
  • INACTIVE INGREDIENTS

    Sodium Palmitate, Sodium Cocoate, Water, Glycerin, Fragrance, Sodium Chloride, EDTA, BHT.

  • SPL UNCLASSIFIED SECTION

    Charm-Tex, Inc. Brooklyn NY 11230

  • PRINCIPAL DISPLAY PANEL - 1.4 gr Bar Soap Carton

    Charm-Tex

    PROVIDERS OF
    CORRECTIONAL SUPPLIES

    ANTIBACTERIAL BAR SOAP
    WRAPPED

    Style Number #H/S1/2
    Contents: 1,000
    Net Wt. 0.5 oz. (1.4gr) Each

    PRINCIPAL DISPLAY PANEL - 1.4 gr Bar Soap Carton
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BAR 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Palmitate (UNII: JQ43KP6296)  
    Sodium Cocoate (UNII: R1TQH25F4I)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetic Acid (UNII: 9G34HU7RV0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40057-3000-11000 in 1 CARTON
    114.17 g in 1 PACKAGE
    2NDC:40057-3000-2500 in 1 CARTON
    242.52 g in 1 PACKAGE
    3NDC:40057-3000-3144 in 1 CARTON
    385 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E02/29/2012
    Labeler - Charm-Tex, Inc (058347543)
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