Label: TRICLOSAN- triclosan soap

  • NDC Code(s): 53175-003-01, 53175-003-02
  • Packager: Dyad Medical Sourcing, LLC
  • 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 July 13, 2015

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  • Active Ingredient:

    Triclosan 0.2%

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  • Purpose:

    Antibacterial

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  • Use:

    For hand washing to decrease bacteria on skin

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  • Inactive Ingredients:

    Sodium Cocoate, Palm Kernelate, Water, Glycerin, Sodium Chloride, Fragrance, Titanium Dioxide.

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  • Warning:

    For external use only. Do not use in eyes. Discontinue if redness or irritation develops.

    Keep out of reach of children

    • Use only as directed
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  • Principal Display Panel - Case Label

    HCS

    Lightly Scented
    Deodorant Soap

    • Gentle Formula
    • Antibacterial

    No. 1-1/2

    NDC 53175-003-01

    Principal Display Panel - Case Label
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  • Principal Display Panel - Case Label

    HCS

    Lightly Scented
    Deodorant Soap

    • Gentle Formula
    • Antibacterial

    No. 3/4

    NDC 53175-003-02

    Principal Display Panel - Case Label
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  • INGREDIENTS AND APPEARANCE
    TRICLOSAN 
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53175-003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 0.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Cocoate (UNII: R1TQH25F4I)  
    Sodium Palmate (UNII: S0A6004K3Z)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53175-003-01 500 in 1 CASE 03/01/2016
    1 42.5 g in 1 PACKAGE; Type 0: Not a Combination Product
    2 NDC:53175-003-02 1000 in 1 CARTON 03/01/2016
    2 21.3 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 03/01/2016
    Labeler - Dyad Medical Sourcing, LLC (078572603)
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