Label: HAND SANITIZER GEL- benzalonium chloride liquid
HAND SANITIZER FOAM- benzalonium chloride liquid
SANITIZINGSOAP- benzalonium chloride 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 June 1, 2020

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

View All Sections
  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, Benyzl alcohol, purified water USP, Etc.

  • Package Label - Principal Display Panel

    NDC: 51706-803 803 package

  • PRINCIPAL DISPLAY PANEL

    51706-804 804 package

  • PRINCIPAL DISPLAY PANEL

    51706-805 805 package

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    benzalonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) 0.74952 mL  in 100 mL
    POLIHEXANIDE (UNII: 322U039GMF) 0.26 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-805-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:51706-805-02244 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    HAND SANITIZER FOAM 
    benzalonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B) 0.74952 mL  in 100 mL
    POLIHEXANIDE (UNII: 322U039GMF) 0.26 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-804-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:51706-804-02244 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    3NDC:51706-804-031200 mL in 1 BAG; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    SANITIZINGSOAP 
    benzalonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) 12 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-803-011200 mL in 1 BAG; Type 0: Not a Combination Product06/01/2020
    2NDC:51706-803-02244 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    3NDC:51706-803-033780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-803, 51706-804, 51706-805)
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!