Label: AFIA ALCOHOL-FREE FOAMING HAND 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 October 28, 2022

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  • Drug Facts

    Active Ingredient. Purpose

    Benzalkonium Chloride 0.1%...........Antimicrobial

    Active Ingredient. Purpose Benzalkonium Chloride 0.1%...........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 doctor if irritation or redness developts, or if condition persists 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, dihyroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • 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 a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Afia Alcohol-Free Foaming Hand Sanitizer

    Afia Alcohol-Free Foaming Hand Sanitizer

    Afia Alcohol-Free Foaming Hand Sanitizer

    Afia Alcohol-Free Foaming Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    AFIA ALCOHOL-FREE FOAMING HAND SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-445
    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
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71023-445-571000 mL in 1 BAG; Type 0: Not a Combination Product10/24/2016
    2NDC:71023-445-293785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
    3NDC:71023-445-32208450 mL in 1 DRUM; Type 0: Not a Combination Product03/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/24/2016
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Registrant - National Chemical Laboratories, Inc. (002289619)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Chemical Laboratories, Inc.002289619manufacture(71023-445)
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