Label: CRAZY AARONS HAND SANITIZER 68% ALCOHOL- alcohol 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 September 22, 2020

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    Ethanol 68% v/v

    Purpose

    Antiseptic

  • Use

    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 fire or flame.

    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.

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

    • Place enough product on hands to cover all surfaces. Rub hands together briskly until dry.

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



  • Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    Ammonium Polyacryloyldimethyl Taurate, Blue 1, Calcium Sodium Borosilicate, FD&C Yellow 5 Aluminum Lake, Fragrance, Glycerin, Mica, Propylene Glycol, Silica, Tin Oxide, Titanium Dioxide, Water

  • PRINCIPAL DISPLAY PANEL

    PDP-Drug Facts

  • INGREDIENTS AND APPEARANCE
    CRAZY AARONS HAND SANITIZER 68% ALCOHOL 
    alcohol hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80032-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BOROSILICATE GLASS (UNII: BOJ6T9AR90)  
    MICA (UNII: V8A1AW0880)  
    DIBUTYLTIN OXIDE (UNII: T435H74FO0)  
    COBALT TITANIUM OXIDE (UNII: CN422GY0TE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    3-(NONYLOXY)1,2-PROPANEDIOL (UNII: 73E9M7IT67)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80032-300-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - Crazy Aaron Enterprises, Inc. (092666531)
    Registrant - Crazy Aaron Enterprises, Inc. (092666531)
    Establishment
    NameAddressID/FEIBusiness Operations
    B & J Group064604222manufacture(80032-300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Action-Pak, Inc.117537305relabel(80032-300) , repack(80032-300)
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