Label: GUARD ALCOHOL-FREE 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 April 20, 2020

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  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    to help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Do not use 

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

    Stop use and ask a doctor if

    irritation develops

    Keep out of reach of children.

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

  • Directions

    • put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
    • Children under 6 years should be supervised when using this product.
  • Inactive ingredients

    Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

  • Questions?

    1-866-695-3030

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    GUARD ALCOHOL-FREE HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-514
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-514-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
    2NDC:63148-514-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
    3NDC:63148-514-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/17/2020
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-514)
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