Label: PUREFOAM ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid

  • 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 November 25, 2020

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  • DRUG FACTS

  • Active ingredient

    Benzalkonium Chloride 0.12%

    Purpose

    Antibacterial Hand Cleaner

  • Uses

    • For hand washing to decrease bacteria on the skin
  • Warnings

    Keep away from fire and flame.

    For external use only

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

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

  • DIRECTIONS

    • Wet hands and desired area.
    • Apply product to adequately cover the surface.
    • Scrub thoroughly for atleast 30 seconds.
    • Rinse

  • Inactive ingredients

    Water (Aqua), glycerin, lauramine oxide, cocamidopropyl hydroxysultaine and cocamide MIPA, cocamidpropyl PG-Dimonium Chloride Phosphate, Fragrance, Benzl Alcohol, Ethylhexylglycerin, Tocopherol, Citric Acid

  • OTHER INFORMATION

    • Store between (15-20C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    PUREFOAM ANTIBACTERIAL HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-547
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    COCAMIDE (UNII: 3YXD33R71G)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74830-547-0159.1 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/31/2020
    Labeler - Economy Polymers and Chemicals (008087603)
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