Label: FOAMING HAND SANITIZER- hand sanitizer aerosol, foam

  • 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 December 22, 2021

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  • Active Ingredient:

    Benzalkonium Chloride 0.1%

  • Purpose

    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 contact, flush eyes with water.

  • Stop use and ask doctor

    if irritation or redness develops, or if condition persists for than 72 hours.

  • Keep out of reach of children

    if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    pump enough foam to thoroughly cover your hand

    rub thoroughly over all surfaces of both hands

    rub hands together briskly until dry

  • Inactive Ingredients:

    Citric Acid, Cocamidopropyl Betaine, Fragrance, Phenoxyethanol, Water

  • Foaming Hand Sanitizer Label 

    Foaming Hand Sanitizing Label

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    hand sanitizer aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23261-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FRAGRANCE ORANGE ORC2000765 (UNII: GX5JI7UXQ7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23261-100-013785 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Sanitor Corporation (797472792)
    Registrant - Sanitor Corporation (797472792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanitor Corporation797472792manufacture(23261-100)
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