Label: ALCOHOL-FREE HAND SANITIZING FOAM- benzalkonium chloride solution

  • NDC Code(s): 63998-764-01, 63998-764-02
  • Packager: United 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 November 9, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

    For external use only

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

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

  • Inactive ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid and fragrance.

  • PRINCIPAL DISPLAY PANEL - 2 Ounce Bottle Label

    UNITED
    LABORATORIES

    United 764

    MICROMOUSSE

    Alcohol-Free
    Hand Sanitizing Foam

    2 FLUID OUNCES

    Eliminates 99.99% of common
    disease-causing germs.

    Made in USA
    1018

    UNITED LABORATORIES, INC.
    320 37th Avenue • St. Charles, IL 60174
    1-800-323-2594 • www.unitedlabsinc.com

    PRINCIPAL DISPLAY PANEL - 2 Ounce Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE HAND SANITIZING FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63998-764
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63998-764-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    2NDC:63998-764-02750 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/01/2019
    Labeler - United Laboratories Inc. (001759737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323MANUFACTURE(63998-764)
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!