Label: GUARDEX HAND SANITIZER GEL- isopropyl alcohol 75% 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 August 21, 2020

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  • Active Ingredient

    Isopropyl Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    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. Flammable. Keep away from heat or flame.

  • Do not use

    On 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.

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

  • Directions

    Place enough product on hands to cover all surfaces.

    Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    -Store between 15-30C (59-86F).

    -Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    glycerin, hydrogen peroxide, Triethanolamine, carbomer, purified water USP

  • Guardex Hand Sanitizer gel

    labellabel

  • INGREDIENTS AND APPEARANCE
    GUARDEX HAND SANITIZER GEL 
    isopropyl alcohol 75% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77390-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL2839 mL  in 3785 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE TRISTEARATE (UNII: HOM72YRP1F)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    (3-BROMOPROPYL)BENZENE (UNII: 6VX623QN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77390-102-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - 21st Century Chemical, Inc. (037798686)
    Registrant - 21st Century Chemical, Inc. (037798686)
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