Label: GUARD HAND SANITIZER- ethyl alcohol 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 May 12, 2020

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  • Active ingredient

    Ethyl Alcohol 65%

    Purpose

    Antiseptic

  • Uses

    for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

  • Warnings

    For external use only

    • flammable
    • keep away from source of heat or fire

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

    Do not use

    • on children less than 2 month of age
    • on open skin wounds
    • on broken or damaged skin
    • if you are pregnant or breastfeeding

    Stop use and ask a doctor if 

    irritation or redness develops and lasts

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults only
    • For occasional and personal use
    • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Other information

    • store at a temperature below 110°F (43°C)
    • may discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer

  • Questions or comments?

    1-866-695-3030

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    GUARD HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-517
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-517-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2020
    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(63148-517)
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