Label: ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH- isopropyl alcohol liquid

  • 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 February 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 75% 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 heat or flame.

    Do not use

    • in children less than 2 months of age
    • 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 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Questions

    (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

    ISOPROPYL
    ALCOHOL 75%

    TOUGH ON GERMS
    EASY ON HANDS

    2fl. oz. • 60mL

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 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:74154-009-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/28/2020
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ion Labs106499791MANUFACTURE(74154-009)
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