Label: FOAMING HAND SANITIZER- alcohol solution

  • NDC Code(s): 50021-020-01, 50021-020-02
  • Packager: Empack Spraytech Inc.
  • 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 November 11, 2020

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  • Active Ingredient(s)

    Ethanol 70% (v/v)

  • 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. Flammability warning. Keep away from open flame and sources of heat.

  • Do not use

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

    When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. 

  • STOP USE

    Stop use and ask a doctor if irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Topical. If swallowed, call a poison control centre or get medical help right away.

  • Directions

    • Adults and children over 2 years 
    • For occasional and personal domestic use 
    • Supervise children under 6 years of age when using this product to avoid swallowing 
    • Place enough product on hands to cover all surfaces. Rub hands together for at least 30 seconds until dry.
  • Other information

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

    Water, Bis-PEG-12 Dimethicone, Glycerin, Aloe Barbadensis Leaf Juice

  • Questions?

    1-866-923-2665

  • SPL UNCLASSIFIED SECTION

    UPC

    Manufactured by Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, Canada L6T 4H6

    www.zytecgermbuster.ca

    Made in Canada

    Lot # and Expiry Date to be embossed on the bottle

  • Package Label - Principal Display Panel

    550 ml; NDC 50021-020-01Foaming Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-020-01550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/11/2020
    2NDC:50021-020-023785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/11/2020
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc.252047519manufacture(50021-020)
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