Label: HAND SANITIZER- benzalkonium chlorida 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 March 24, 2021

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  • Active Ingredient

    benzalkonium chloride .2%. Purpose: Antiseptic

  • 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.

  • 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

    Directions. Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • Store between 41-80F (5-27C).
    • Avoid freezing and excessive heat above 40C (104F).
  • Inactive ingredients

    Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract.

  • Package Label - Principal Display Panel

    1L NDC: 78522-102-00 Kids 1L label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chlorida gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78522-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    BIRCH TRITERPENES (UNII: BX09B0RQR0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78522-102-001 L in 1 BOTTLE; Type 0: Not a Combination Product03/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/16/2020
    Labeler - Northmed (662588132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northmed662588132manufacture(78522-102) , pack(78522-102) , label(78522-102)
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