Label: EXTRA STENGTH HAND SANITIZER ZYTEC GERM BUSTER- alcohol 80%w/w aerosol, spray

  • NDC Code(s): 50021-008-01, 50021-008-02, 50021-008-03, 50021-008-04, view more
    50021-008-05, 50021-008-06, 50021-008-07, 50021-008-08, 50021-008-09
  • 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 April 23, 2020

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  • Active Ingredients (w/w )

    Ethyl Alcohol 80%

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to help reduces bacteria that potentially can cause disease. Recommended for repeated use. For use when soap and

    water are not available

  • Warnings

    For external use only. Flammable. Keep away from fire or flame

    Do not use

    • in children less than 2 months age
    • on open skin wounds

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water

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

  • Directions

    • Hold can at 10 inches distance
    • Spray 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 at room temperature 15-30 C (59-86°F). May stain surfaces and fabrics.
    • Avoid freezing and extrensive heat avbove 40C (104F)
  • Inactive Ingredients

    Water (Aqua), Isobutane, Fragrance (Parfum).

  • Questions ?

    1-866-923-2665

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

    UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

  • Principal Display Panel -

    Extra Stength Hand Sanitizer Spray

    Alcohol Antiseptic 80%

    Packge size ranges between 51g (100 ml) to 252g (500 ml)

    Principal Display Panel - Extra Stength Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    EXTRA STENGTH HAND SANITIZER  ZYTEC GERM BUSTER
    alcohol 80%w/w aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LIME (CITRUS) (UNII: 8CZS546954)  
    ISOBUTANE (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-008-0151 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    2NDC:50021-008-02100 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    3NDC:50021-008-03125 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    4NDC:50021-008-04200 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    5NDC:50021-008-05253 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    6NDC:50021-008-06400 g in 1 CAN; Type 0: Not a Combination Product04/08/2020
    7NDC:50021-008-0770 g in 1 CAN; Type 0: Not a Combination Product04/15/2020
    8NDC:50021-008-08352 g in 1 CAN; Type 0: Not a Combination Product04/15/2020
    9NDC:50021-008-09176 g in 1 CAN; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2020
    Labeler - Empack Spraytech Inc. (252047519)
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