Label: NORTHMED 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 July 22, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.2%

  • Purpose

    Antiseptic

  • 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.

    Do not use

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

    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

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

  • Directions

    • Apply a small amount of gel to hands and massage. Wait for it to dry. The exposure time is 15-0 seconds.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Water, Glycerine, Panthenol, Aloe vera, Hydroxyethyl cellulose, Tetrasodium Glutamate Diacetate, Fragrance, Linalool, Citronellol

  • Package Label - Principal Display Panel

    2 mL

    Label

    50 mL

    Label

    250 mL

    Label

    1000 mL

    Label

    4000 mL

    Label

  • INGREDIENTS AND APPEARANCE
    NORTHMED HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78522-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78522-010-0124 in 1 PACKAGE07/22/2020
    12 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:78522-010-0250 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2020
    3NDC:78522-010-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    4NDC:78522-010-041000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2020
    5NDC:78522-010-054000 mL in 1 BAG; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - Northmed SIA (662588132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northmed SIA662588132manufacture(78522-010)
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