Label: AFIA FOAMING E2 SANITIZING HAND CLEANER- 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 January 18, 2017

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  • Drug Facts

    Active Ingredient. Purpose

    Benzalkonium Chloride 0.15%...........Antimicrobial hand Cleaner

    Active

  • Uses

    • Uses • For hand-washing to decrease bacteria on the skin. Helps prevent cross contamination by hand contact.

    Uses

  • Warnings:

    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.

    Warnings

  • Directions

    • Wet hands and wrist with water. Pump 2 strokes of foam into palm of hand. • Rub thoroughly over all surfaces of both hands and wrist, include between fingers and under cuticles, for 60 seconds. • Rinse hands completely and dry thoroughly.

    Dosage

  • Inactive ingredients

    Water / Cetrimonium Chloride / Coco Glucoside / Dihydroxyethyl Cocamine Oxide / Laurtrimonium Chloride / Glycereth-17 Cocoate / Cocamidopropyl Hydroxysultaine / Hydroxyethylcellulose / Citric Acid

    Inactive ingredients

  • Uses

    For hand-washing to decrease bacteria on the skin. Helps prevent cross contamination by hand contact.

    uses

  • 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.

    Keep out of reach

  • PRINCIPAL DISPLAY PANEL

    Afia Foaming E2 Sanitizing Hand Cleaner

    Final PackageCarton

  • INGREDIENTS AND APPEARANCE
    AFIA FOAMING E2 SANITIZING HAND CLEANER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-448
    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
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71023-448-571000 mL in 1 BAG; Type 0: Not a Combination Product01/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/18/2017
    Labeler - National Chemical Laboratories, Inc. (002289619)
    Registrant - National Chemical Laboratories, Inc. (002289619)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Chemical Laboratories, Inc.002289619manufacture(71023-448)
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