Label: CLEAN HANDS INSTANT HAND SANITIZER- benzalkonium chloride liquid

  • NDC Code(s): 50254-457-10, 50254-457-12, 50254-457-13, 50254-457-17, view more
    50254-457-18, 50254-457-27
  • Packager: Beaver Research Company
  • 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 January 7, 2020

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  • Drug Facts Box OTC-Active Ingredient Section

    benzalkonium chloride USP 0.13%

  • Drug Facts Box OTC-Indications & Usage Section

    For hand-washing to decrease bacteria on the skin, only when water is not available

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box-OTC When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box-OTC Stop Use Section

    irritation and redness develop

  • Drug Facts Box-OTC Keep Out Of Reach Of Children Section

    If swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box-OTC Dosage & Administration Section

    press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

    rub hands together until dry

    wash hands with soap and water at earliest opportunity

  • Drug Facts Box-OTC Inactive Ingredient Section

    water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

  • Quick Defense Instant Hand Sanitizer

    product lable

    Quick Defense Instant Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    CLEAN HANDS INSTANT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50254-457
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50254-457-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/07/2020
    2NDC:50254-457-121000 mL in 1 BAG; Type 0: Not a Combination Product01/07/2020
    3NDC:50254-457-13800 mL in 1 BAG; Type 0: Not a Combination Product01/07/2020
    4NDC:50254-457-1850 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2020
    5NDC:50254-457-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/07/2020
    6NDC:50254-457-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/07/2020
    Labeler - Beaver Research Company (044960466)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(50254-457)
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