Label: HAND WASH- benzalkonium chloride soap

  • NDC Code(s): 37808-952-45, 37808-952-96
  • Packager: Harmon Stores, Inc
  • 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 June 28, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzalkonium chloride 0.13%

  • purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • warnings

    For external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5

  • Questions?

    1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78204

    MADE IN THE U.S. AND IMPORTED PARTS, 

    We hope you are satisfied with this product.

    If not, we will cheerfully refund your money.

    Lot Number: on package, 1-888-593-0593

  • principal display panel

    HILL COUNTRY ESSENTIALS

    Antibacterial Foaming Hand Soap

    Removes Dirt & Helps Kill Harmful Germs

    7.5 FL OZ (221 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-952
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-952-96221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2016
    2NDC:37808-952-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2016
    Labeler - Harmon Stores, Inc (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-952)