Label: HAND SANITIZER- benzalkonium chloride gel

  • 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 6, 2021

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Directions

    ▪ Pump a small amount of foam into palm of hand

    ▪ Rub thoroughly over all surfaces of both hands for 15 seconds

    ▪ Rinse with potable water

  • Keep out of reach of children

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

  • 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.

  • Uses

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • Inactive ingredients

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

  • Hand Sanitizer

    hand sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64972-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3068 g  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64972-100-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/18/2020
    Labeler - Goodwin Co. (183495282)
    Registrant - Goodwin Co. (183495282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodwin Co.183495282manufacture(64972-100)
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