Label: GERM FREE TOPICAL ANTISEPTIC- benzalkonium chloride gel

  • NDC Code(s): 71884-008-02
  • Packager: Enviro Specialty Chemicals 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 February 23, 2022

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  • Drug Facts

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

  • Purpose:

    First aid antiseptic - Topical skin treatment

  • Uses:

    First aid soothing and germ protection for:

    • Minor cuts • Scrapes • Burns • Skin irritations • Minor abrasions

  • Warnings:

    Do not freeze. For external use only.

    Do not use in ears, eyes or mouth.

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

    • Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.

    • Keep out of reach of children.

    • Children should be supervised when using this product.

  • Directions:

    Apply liberally over affected area, recommended for repeat application regularly.

  • Inactive Ingredients:

    Aloe Barbadenis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Hydroxyethyl cellulose, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

  • Questions?

    +1(888) 331-8332, Mon-Fri 9:00AM-5:00PM (EST)

  • SPL UNCLASSIFIED SECTION

    Formulated with Zetrisil®

    One spray lasts all day

    Long lasting, alcohol-free protection from germs.

    FOR MINOR CUTS, SCRAPES & BURNS

    KILLS 99.99% OF HARMFUL GERMS

    MAXIMUM STRENGTH

    MOISTURIZES WITH ALOE VERA

    MADE IN THE USA

    Distributed by: ESC Brands, LLC.

    664 Old Hargraves Road - Suite B

    Lexington, NC 27295

    www.germ-free24.com

  • Packaging

    GERMFREE

  • INGREDIENTS AND APPEARANCE
    GERM FREE TOPICAL ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    LAURETH-4 (UNII: 6HQ855798J)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-008-0257 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2018
    Labeler - Enviro Specialty Chemicals Inc (202621850)
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