Label: ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH (ALCOHOL-FREE)- benzalkonium chloride 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 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial and First aid antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.
    • For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.
  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

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

  • Directions

    • Pump onto hands as needed. Rub briskly together until dry.
    • Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.
  • Inactive ingredients

    ionized water, urea

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 1 gal Bottle Label

    ENVIROPURE™

    ANTIBACTERIAL

    HAND
    SANITIZER

    MAXIMUM STRENGTH

    Eliminates 99.99% of Germs

    alcohol-free
    triclosan-free & fragrance-free

    BENZALKONIUM CHLORIDE 0.13%

    BAC-D
    BACTERIAL DEFENSE®

    128 fl. oz. (1 gal)

    PRINCIPAL DISPLAY PANEL - 1 gal Bottle Label
  • INGREDIENTS AND APPEARANCE
    ENVIROPURE ANTIBACTERIAL HAND SANITIZER MAXIMUM STRENGTH (ALCOHOL-FREE) 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    urea (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74154-004-103785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cemi International015038336MANUFACTURE(74154-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!