Label: HAND RX ANTIBACTERIAL HAND- benzalkonium chloride liquid

  • NDC Code(s): 22431-021-01
  • Packager: BLUE CROSS LABORATORIES, 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 August 1, 2020

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

View All Sections
  • Drug Facts Active Ingredient

    Benzalkonium Chloride 0.13 percent

  • Purpose

    Antibacterial

  • Uses:

    For hand washing to decrease bacteria on the skin.

  • Warnings:

    For external use only.

    When using this product Avoid contact with eyes. In case of eye contact, flush with water.

  • Stop use and ask a doctor if

    irritation and redness develops.

  • Keep out of reach of children.

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

  • Directions

    • Wet hands as needed
    • Lather vigorously for at least 15 seconds
    • Wash skin, rinse and dry thoroughly.
  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No.40, D&C Red No. 33

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND RX ANTIBACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-021-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - BLUE CROSS LABORATORIES, INC. (008298879)
    Registrant - BLUE CROSS LABORATORIES, INC. (008298879)
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!