Label: FOAMING HAND SANITIZER liquid

  • 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 13, 2013

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

View All Sections
  • 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 reach of children

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

  • Directions:

    Pour contents into the Foaming Dispenser reservoir. For first use applications, pump dispenser a few time to prime. Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

  • Other Information

    Store below 110 °F (43 °C). May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereteh-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, aloe barbadensis leaf juice.

  • PRINCIPAL DISPLAY PANELFOAMING HAND SANITIZER NET CONTENTS: 3.785 LITERS 

    FOAMING HAND SANITIZER

    FOAMING HAND SANITIZER

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    foaming hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68878-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68878-119-113785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2008
    Labeler - Theochem Laboratories Inc (004100038)
    Registrant - Theochem Laboratories Inc (004100038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Theochem Laboratories Inc004100038manufacture(68878-119)
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!