Label: GUARDRX GEL HAND SANITIZER- gel hand sanitizer 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 21, 2020

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  • ACTIVE INGREDIENT

    Ethanol 73%

  • Purpose:

    Antiseptic

  • Uses:

    -For hand washing to decrease bacteria on skin.

    -Recommended for repeated use.

  • WARNINGS:

    -Flammable, keep away from fire or flame.

    -For external use only.

    -Do not use in eyes. If contact occurs, flush thoroughly with water.

    -Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

    -Do not use other than directed.

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • INACTIVE INGREDIENT

    Aqua, Glycerin, Hydroxypropyl Cellulose, Triethanolamine, Hydrogen Peroxide,

  • 59.15 mL NDC: 74306-234-02

    GuardRx Gel Label 2oz

  • 118.29 mL NDC: 74306-234-04

    GuardRx Gel Label 4oz

  • 236.58 mL NDC: 74306-234-08

    Guard Rx Gel Label 8oz

  • 499.8 mL NDC: 74306-234-16

    GuardRx Gel label 16.9oz

  • INGREDIENTS AND APPEARANCE
    GUARDRX GEL HAND SANITIZER 
    gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74306-234-0259.15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
    2NDC:74306-234-04118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
    3NDC:74306-234-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
    4NDC:74306-234-16499.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/21/2020
    Labeler - GPS Associates (096942063)
    Registrant - GPS Associates, LLC (096942063)
    Establishment
    NameAddressID/FEIBusiness Operations
    GPS Associates096942063manufacture(74306-234)
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