Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride aerosol, foam

  • NDC Code(s): 60933-200-00
  • Packager: FULLER INDUSTRIES, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active ingredient

    Benzalkonoium Chloride 0.1%

    Purpose

    Antimicrobial

  • Uses

    - For hand sanitizing to decrease the bacteria on skin.

    - Recommended for repeated use

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes  In case of eye contact, flush eyes with water.

    Stop use and ask a doctor

    if irritation or redness develops, or if condition persists for more than 72 hours

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    - Pump a small amount of foam into palm of hand

    - Rub thoroughly over all surfaces of both hands

    - Rub hands together briskly until dry

  • Inactive Ingredients:

    Water; Lauramine Oxide; Undeceth-7; Disodium EDTA; DMDM Hydantoin; Fragrance; Citric Acid; FD&C Red #33; FD&C Blue #1/

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60933-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    UNDECETH-7 (UNII: R6B5PCO2JN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60933-200-001000 mL in 1 BAG; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/01/2017
    Labeler - FULLER INDUSTRIES, INC (078704329)
    Establishment
    NameAddressID/FEIBusiness Operations
    FULLER INDUSTRIES, INC078704329manufacture(60933-200)
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