Label: BENZALKONIUM CHLORIDE- benzalkonium chloride 0.13% soap

  • 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 8, 2022

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

View All Sections
  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hand 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, lauramine oxide, PEG-150 distearate, sodium chloride, cetrimonium chloride, decyl glucoside, glycerin, fragrance, disteareth-75 IPID, citric acid, tetrasodium EDTA, DMDM hydantoin, benzophenone-4, yellow 5, red 40, red 33

  • Questions?

    Call 1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    Distributed by HEB San Antonio, TX 78204

    Made in the USA of US 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 Hand Soap

    Moisturizing

    7.5 FL OZ (221 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    benzalkonium chloride 0.13% soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-278
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-278-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2016
    Labeler - HEB (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-278)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-278)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!