Label: FOAMING HAND- benzalkonium chloride lotion

  • 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 9, 2023

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

View All Sections
  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    for handwashing to decrese 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 develop
    • condition persists for more than 72 hours
  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Other Information

    • do not store above 105°F
    • may discolor some fabrics
    • harmful to wood finshes and plastics
  • Inactive ingredients

    water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

  • Rear label text

    Manufactured for Cintas Corp.

    Mason, OH 45040

    800-CINTAS1

    NSF Nonfood Compounds Program

    Product is NSF certified for use as a hand sanitizer in and around food processing areas.

    CiNTAS

    800mL/27.0 FL OZ

  • principal display panel

    HAND

    SOAP

    ANTIBACTERIAL

    FOAM

    image description

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-224
    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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-224-71800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - Cintas Corp (056481716)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(42961-224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(42961-224)
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!