Label: FOAM HAND SANITIZER- alcohol 70% aerosol, foam

  • NDC Code(s): 50021-007-01, 50021-007-02
  • 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 April 7, 2020

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  • Active Ingredients (v/v )

    Ethyl Alcohol 70%

  • 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

    • Place 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

    Aloe Barbadensis Leaf Juice, Aqua, Bis-PEG-12 Dimethicone, Ceteareth-25, Glycerin, Isobutane, Stearyl alcohol.

  • 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 - Foaming Hand Sanitizer

    Foaming Hand Sanitizer

    Alcohol Antiseptic 70%

    Optional size ranges between 100g to 325g

    Principal display panel - Foaming H Sanitizer

  • INGREDIENTS AND APPEARANCE
    FOAM HAND SANITIZER 
    alcohol 70% aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-007
    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) 0.07 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.7 g  in 100 mL
    CETEARETH-25 (UNII: 8FA93U5T67) 2.45 g  in 100 mL
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 1.96 g  in 100 mL
    BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4) 1.27 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 mL
    ISOBUTANE (UNII: BXR49TP611) 9 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-007-01117 mL in 1 CAN; Type 0: Not a Combination Product04/07/2020
    2NDC:50021-007-02381 mL in 1 CAN; Type 0: Not a Combination Product04/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/07/2020
    Labeler - Empack Spraytech Inc. (252047519)
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