Label: ORIGINAL ANTIBACTERIAL FOAMING HAND SOURCE- triclosan soap 

  • Label RSS
  • NDC Code(s): 22431-526-01
  • Packager: Blue Cross Laboratories, 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 04/13

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  • ACTIVE INGREDIENT

    Active ingredient                purpose

    Triclosan 0.46 %                antibacterial

    Uses: decrease bacteria on the skin

    Keep out of reach of children

    If irritation occurs discontinue use of product

    Warnings for external use only

    Avoid eye contact. If contact occurs rinse thoroughly with water.

    Directions

    Pump foam into hands into hands, lather vigorously and rinse.

    Water (aqua), sodium laureth sulfate, dipropylene glycol, glycerin, sodium PCA, ammonium lauryl sulfate, cocamidopropyl betaine, polyquaternium 10, fragrance, disodium phosphate, citric acid, red 4, yellow 5.

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  • PRINCIPAL DISPLAY PANEL

     

    image of back label
    image of front label

      

    Anti Bacterial foaming hand soap

    original

    7.5 Fl. Oz. (222 mL)

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  • INGREDIENTS AND APPEARANCE
    ORIGINAL ANTIBACTERIAL FOAMING HAND  SOURCE
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:22431-526
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN .46 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM LAURETH SULFATE  
    DIPROPYLENE GLYCOL  
    GLYCERIN  
    SODIUM PYRROLIDONE CARBOXYLATE  
    AMMONIUM LAURYL SULFATE  
    COCAMIDOPROPYL BETAINE  
    POLYQUATERNIUM-10 (400 CPS AT 2%)  
    CITRIC ACID MONOHYDRATE  
    FD&C RED NO. 4  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:22431-526-01 222 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/22/2011
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Blue Cross Laboratories, Inc. (008298879)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Liyuan Daily Chemical Products 530766098 manufacture(22431-526)
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