Label: ANTIMICROBIAL FOAM- triclosan soap 

  • Label RSS
  • 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 12/12

If you are a consumer or patient please visit this version.

  • Antimicrobial Foam

    ​Active Ingredient

    ​Triclosan 0.30%

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  • Antimicrobial Foam

    Uses

    • ​Antibacterial hand cleaner.
    • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.
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  • Antimicrobial Foam

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
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  • Antimicrobial Foam

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 0.8 mL of product onto wet palm.
    • Rub hands together to distribute product, then rinse hands with clean.
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  • Antimicrobial Foam

    Inactive Ingredients

    ​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

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  • Antimicrobial Foam

    Purpose

    ​Antibacterial

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  • Antimicrobial Foam

    KEEP OUT OF REACH OF CHILDREN

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  • Antimicrobial Foam

    AFFEX CLEANING SOLUTIONS

    Antimicrobial Foam Soap

    Foaming Skin Cleanser with Triclosan

    MEDICAL EMERGENCY:

    (800)424-9300

    NET CONTENTS: 1000 mL

    ITEM #305-60

    Afflink 305.jpg

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  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAM 
    tricolsan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54057-305
    Route of Administration Topical DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POTASSIUM COCOATE  
    PROPYLENE GLYCOL  
    GLYCERIN  
    EDETATE SODIUM  
    DMDM HYDANTOIN  
    FD&C YELLOW NO. 5  
    ALOE VERA Leaf  
    FD&C RED NO. 40  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54057-305-60 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/12/2012
    Labeler - Afflink, Inc. (023121150)
    Registrant - Betco Corporation, Ltd. (005050158)
    Establishment
    Name Address ID/FEI Business Operations
    Betco Corpo, Ltd. 005050158 manufacture(54057-305), label(54057-305), pack(54057-305)
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