Label: ALCOHOL FREE FOAM SANITIZER- benzalkonium chloride soap

  • 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 December 13, 2012

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  • Alcohol Free Foam Sanitizer

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • Alcohol Free Foam Sanitizer

    Uses

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

  • Alcohol Free Foam Sanitizer

    Purpose

    Antiseptic

  • Alcohol Free Foam Sanitizer

    KEEP OUT OF REACH OF CHILDREN

  • 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

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE FOAM SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-304
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54057-304-601000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Afflink, Inc. (023121150)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158manufacture(54057-304)
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