Label: FOAMING HAND SANITIZER- 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 March 21, 2022

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • Use

    Decreases bacteria on hands.

  • Warnings

    Use only directed. For external use only.
    When using this product avoid contact with eyes.
    lf contact occurs, rinse thoroughly with water.
    Stop use and ask doctor if irritation and redness develop or increase.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Dispense a palm-sized amount onto hands·Rub hands together until dry

  • Inactive ingredients

    Water (Aqua),PEG-40 Hydrogenated Castor Oil, Glycerin, Fragrance
    (ParfumDidecyldimonium Chloride, Phenoxy-
    ethanol, Polyaminopropyl Biguanide, Citric Acid,
    Citrus Limon (lemon)Peel Oil, Yellow 5(Cl19140), Red 4 (CI 14700)

    Eucalyptus Globulus Leaf Oil,Blue 1(CI 42090)

    Vanilla Planifolia Fruit Oil,Red 33(CI 172000)

    Mangifera Indica(mango)Seed Oil

  • Package Label - Principal Display Panel

    1234

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-940
    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
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    MANGO SEED OIL (UNII: K8LOR30915)  
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    LEMON OIL (UNII: I9GRO824LL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-940-0151 g in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-940)
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