Label: AFIA ALCOHOL-FREE FOAMING HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 71023-045-29, 71023-045-32, 71023-045-57
  • Packager: National Chemical Laboratories, Inc.
  • 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 April 28, 2023

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  • Drug Facts

    Active Ingredient. Purpose

    Benzalkonium Chloride 0.13%....... Antimicrobial.

  • Uses

    For hand sanitizing to decrease bacteria on the 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 persist for more than 72 hours.

  • 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, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Fragrance, Glyceth-17 Cocoate, Citric Acid

  • Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Afia Alcohol-Free Foaming Hand Sanitizer

    Afia Alcohol-Free Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    AFIA ALCOHOL-FREE FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-045
    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
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71023-045-571000 mL in 1 BAG; Type 0: Not a Combination Product05/08/2023
    2NDC:71023-045-293785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2023
    3NDC:71023-045-32208175 mL in 1 DRUM; Type 0: Not a Combination Product05/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2023
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Chemical Laboratories, Inc.002289619manufacture(71023-045)
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