Label: SANITIZER STATION HAND SANITIZER FOAM- benzalkonium chloride solution

  • 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 January 7, 2021

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  • Drug Facts

  • Active Ingredient[s]

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use[s]

    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.

    Do not use
    • in children less than 2 months of age
    • on open skin wounds

    When using this product avoid contact with eyes.
    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask 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

    • Pump a small amount of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands.
    • Continue to rub hands until dry.
  • Inactive Ingredients

    deionized water, glycerin, aloe barbadensis leaf juice, lauramine oxide, dimethyltetradecylamine oxide, fragrance, DMDM hydantoin (preservative). 

  • SPL UNCLASSIFIED SECTION

    • Non-Alcoholic Formulation
    • Kills viruses, germs and bacteria
    • Fragranced

    www.sanitizer-station.net

    Manufactured by Shotwell Hydrogenics LLC, 10001
    West l-20, Suite F-3 Midland, TX 70760
    Distributed by Sanitizer Station, 101 Industrial Ct, Conroe, TX, 77301

  • Packaging

    Foam

  • INGREDIENTS AND APPEARANCE
    SANITIZER STATION HAND SANITIZER FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82062-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82062-201-503785 mL in 1 CONTAINER; Type 0: Not a Combination Product01/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/07/2021
    Labeler - Pharmore Group LLC DBA Sanitizer Station (118146049)
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