Label: ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel

  • NDC Code(s): 74621-006-02
  • Packager: Aogrand International Trade Corporation
  • 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 February 11, 2023

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1%. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    • hand Sannitizer to help decrease bacteria on the skin, when water, soap & towel are not available.
    • recommended for repeated use
  • Warnings

    For external use only.

  • DO NOT USE

    Do not apply around eyes. Do not use in ears & mouth.

  • When using this product

    avoid contact with eyes. In case of contact, flush eyes with water.

  • Stop use and ask a doctor

    if redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    • Place enough product into your palms and thoroughly spread on both hands
    • rub into skin until dry
  • Inactive ingredients

    Cocamidopropylamine oxide, C12-20 Alkyl glycoside, glycerin, hydroxyethyl cellulose, Casone (methylisothiazolinone and methylchloroisothiazolinone), citric acid, deionized water

  • Other information

    • store below 110F (43C)
    • may discolor certain fabrics or surfaces
  • Package Label - Principal Display Panel

    480g NDC: 74621-006-02

    PDP

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74621-006
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    WATER (UNII: 059QF0KO0R)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74621-006-02480 g in 1 BOTTLE; Type 0: Not a Combination Product05/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/23/2020
    Labeler - Aogrand International Trade Corporation (421353092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aogrand International Trade Corporation421353092manufacture(74621-006)
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