Label: HAND SANITIZER HAND RX- ethyl alcohol liquid

  • 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 July 10, 2020

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  • ACTIVE INGREDIENT

    Active ingredients       purpose

    Ethyl Alcohol 62%       Antimicrobial        

    Kills over 99% of most common germs

    Keep out of reach of children

    Keep out of eyes.In case of eye contact immediately flush eyes with water then contact physician.

    Warning: flammable. Keep away from flame. If swallowed, contact physician. For external use only. Do not store above 110 degrees farenheit.

    directions:

    put a thumbnail size amount in your palm and rub your hands together briskly until dry

    Children under 6 years of age should be supervised when using Hand Rx.

    Inactive Ingredients: Water, Glycerin, Propylene Glycol, Carbomer

  • PRINCIPAL DISPLAY PANEL

    Hand Rx

    Hand Sanitizer

    Kills 99.99% of germs

    8 Fl Oz. (236 ml)

    back label

    front label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  HAND RX
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-581
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-581-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2010
    2NDC:22431-581-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2010
    3NDC:22431-581-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2010
    4NDC:22431-581-041180 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/12/2010
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Blue Cross Laboratories, Inc. (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Laboratories, Inc.008298879manufacture(22431-581)
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