Label: ALCOHOL FREE FOAMING HAND SANITIZER- benzalkonium chloride soap

  • NDC Code(s): 65601-700-03, 65601-700-04, 65601-700-05, 65601-700-29, view more
    65601-700-53, 65601-700-55, 65601-700-57, 65601-700-88
  • Packager: Betco Corporation, Ltd.
  • 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 September 11, 2020

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  • Alcohol Free Foaming Hand Sanitizer

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • Alcohol Free Foaming Hand Sanitizer

    Uses

    • Hand sanitizer to remove microorganisms on the skin.
    • Use this product when soap and water are not available.
  • Alcohol Free Foaming Hand Sanitizer

    Warnings

    • For external use only.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Alcohol Free Foaming Hand Sanitizer

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 2 pumps of product onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
  • Alcohol Free Foaming Hand Sanitizer

    Inactive Ingredients

    Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone,  PEG-3 Cocamide, Fragrance, Methyl Chloro Isothiazolinone, Methyl Isothiazolinone,  D&C Green #5.

  • Alcohol Free Foaming Hand Sanitizer

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • Alcohol Free Foaming Hand Sanitizer

    Purpose

    Antiseptic

  • Alcohol Free Foaming Hand Sanitizer

    KEEP OUT OF REACH OF CHILDREN

  • Alcohol Free Foaming Hand Sanitizer

    5329880455

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE FOAMING HAND SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-700
    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
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ACETALDEHYDE (UNII: GO1N1ZPR3B)  
    GERANIOL (UNII: L837108USY)  
    HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    MYRCENE (UNII: 3M39CZS25B)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    PEG/PPG-15/15 ALLYL ETHER ACETATE (UNII: 8RP39FN7AJ)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    ALCOHOL (UNII: 3K9958V90M)  
    LIME OIL (UNII: UZH29XGA8G)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    DIOXANE (UNII: J8A3S10O7S)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    LEMON OIL (UNII: I9GRO824LL)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-700-5350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2016
    2NDC:65601-700-291000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2016
    3NDC:65601-700-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2016
    4NDC:65601-700-57550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201609/11/2020
    5NDC:65601-700-55207900 mL in 1 DRUM; Type 0: Not a Combination Product01/01/2016
    6NDC:65601-700-03750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/201607/15/2020
    7NDC:65601-700-051250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/15/201609/11/2020
    8NDC:65601-700-88500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (024492831)
    Registrant - Betco corporation, Ltd. (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.024492831manufacture(65601-700) , pack(65601-700) , label(65601-700)
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