Label: ALCOHOL FREE FOAM SANITIZER- benzalkonium chloride 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.

  • Alcohol Free Foam Sanitizer

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

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  • Alcohol Free Foam Sanitizer

    Uses

    • Use in a variety of public facilities.
    • Use this product when soap and water are not available.
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  • Alcohol Free Foam Sanitizer

    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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  • Alcohol Free Foam Sanitizer

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto dry hands. Rub hands together to distribute product
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  • Alcohol Free Foam Sanitizer

    Inactive Ingredients

    Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.

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  • Alcohol Free Foam Sanitizer

    Purpose

    Antiseptic

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  • Alcohol Free Foam Sanitizer

    KEEP OUT OF REACH OF CHILDREN

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  • Alcohol Free Foam Sanitizer

    AFFEX Cleaning Solutions

    Alcohol Free Foam Sanitizer

    Non Alcohol hand Sanitizer

    Mediucal Emergency:

    (800)424-9300

    NET CONTENTS: 1000 mL

    ITEM #304-60

    Afflink 304.jpg

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE FOAM SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54057-304
    Route of Administration Topical DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PYRROLIDONE CARBOXYLATE  
    POLYETHYLENE GLYCOL 400  
    DIMETHICONE  
    DMDM HYDANTOIN  
    PEG-6 COCAMIDE  
    IODOPROPYNYL BUTYLCARBAMATE  
    D&C GREEN NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54057-304-60 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/12/2012
    Labeler - Afflink, Inc. (023121150)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    Name Address ID/FEI Business Operations
    Betco Corporation, Ltd. 005050158 manufacture(54057-304)
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