Label: ANTIBACTERIAL BAR- triclosan soap

  • NDC Code(s): 40057-3000-1, 40057-3000-2, 40057-3000-3
  • Packager: Charm-Tex, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • Active Ingredient

    Triclosan 0.3%

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  • Purpose

    Antibacterial

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  • USES

    For washing to decrease bacteria on the skin.

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  • 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.

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  • DIRECTIONS

    • Wet bar with water.
    • Later vigorously and wash skin.
    • Rinse and dry thoroughly.
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  • INACTIVE INGREDIENTS

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

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  • SPL UNCLASSIFIED SECTION

    Charm-Tex, Inc. Brooklyn NY 11230

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BAR 
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:40057-3000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (Triclosan) Triclosan 0.3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Palmitate  
    Sodium Cocoate  
    Water  
    Glycerin  
    Sodium Chloride  
    Edetic Acid  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:40057-3000-1 1000 in 1 CARTON
    1 14.17 g in 1 PACKAGE
    2 NDC:40057-3000-2 500 in 1 CARTON
    2 42.52 g in 1 PACKAGE
    3 NDC:40057-3000-3 144 in 1 CARTON
    3 85 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333E 02/29/2012
    Labeler - Charm-Tex, Inc (058347543)
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