Label: AFIA FOAMING ANTI-BACTERIAL HAND CLEANER- benzalkonium chloride soap

  • NDC Code(s): 71023-046-29, 71023-046-57
  • 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 May 8, 2023

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  • Drug Facts

    Active Ingredient. Purpose

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

  • USE

    For hand washing to decrease bacteria on the skin

  • Uses

    For hand washing to decrease bacteria on the skin

  • 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.

  • Directions

    • Wet a hand. Pump one or two stokes of foam, into palm of hand.
    • Rub thoroughly over all surfacesof both hands for 30 seconds
    • Rinse hands and dry thoroughly.
  • Inactive ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycereth-2 Cocoate, Phenoxyethanol, Cocamidopropyl Hydroxysultaine, fragrance, Benzoic Acid, Methylisothiazolinone, FD&C yellow 5, FD&C blue 1

  • Warnings:

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

  • PRINCIPAL DISPLAY PANEL

    Afia Anti-Bacterial Foaming Hand Cleaner

    Afia Anti-Bacterial Foaming Hand Cleaner labelAfia Anti-Bacterial Foaming Hand Cleaner

  • INGREDIENTS AND APPEARANCE
    AFIA FOAMING ANTI-BACTERIAL HAND CLEANER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-046
    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
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71023-046-571000 mL in 1 BAG; Type 0: Not a Combination Product05/08/2023
    2NDC:71023-046-293785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/08/2023
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Registrant - National Chemical Laboratories, Inc. (002289619)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Chemical Laboratories, Inc.002289619manufacture(71023-046)
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