Label: INSTANT HAND SANITIZER- benzalkonium chloride gel

  • 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 September 5, 2020

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

View All Sections
  • Active ingredient

    Benzalkonium Chloride 0.095%

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

  • When using this product

    • Avoid contact with eyes and lips.
    • If contact occurs, rinse with water.
  • Stop using this product and consult a doctor If

    irritation or redness develops.

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    • Rub dime sized amount between hands until dry.
    • For use by children under 6 years, adult supervision is required.

  • Inactive ingredients

    Water, Polyquaternium-37, Glycerin, Propylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Fragrance, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    image of bottle front label

    image of bottle back label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69583-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.95 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69583-035-0135 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2020
    Labeler - Fun Zone, Inc. (803572929)
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!