Label: ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH- alcohol spray

  • 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 January 22, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Alcohol 80% 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. Flammable. Keep away from heat or flame.

    Do not use in children less than 2 months of age or on open skin wounds

    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.

  • 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 between 15-30C (59-86F).

    Avoid freezing and excessive heat above 40C(104F)

  • Inactive Ingredients

    Glycerin, hydrogen peroxide, purified water USP

  • Questions or Comments?

    973-575-6591

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Windmill Health Products®
    10 Henderson Drive
    West Caldwell, NJ 07006

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    ENVIROPURE™

    ANTIBACTERIAL

    HAND
    SANITIZER

    MAXIMUM STRENGTH

    ALCOHOL 80%

    TOUGH ON GERMS
    EASY ON HANDS

    Misting Spray
    2fl. oz. • 60mL

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74154-010-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/29/2021
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cemi International015038336MANUFACTURE(74154-010)
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