Label: MY-SHIELD TOPICAL ANTISEPTIC- benzalkonium chloride gel

  • NDC Code(s): 71884-025-01, 71884-025-04, 71884-025-06, 71884-025-08
  • 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 24, 2022

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

  • 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 repeated use.

  • INACTIVE INGREDIENTS:

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

  • Questions?

    +1(888) 331-8332, M-F, 9AM-5PM (EST)

  • SPL UNCLASSIFIED SECTION

    FAST ACTING 15 SECOND FORMULA

    CONTAINS ALOE VERA

    Alcohol-Free

    Long lasting, soothing protection from germs. 

    KILLS 99.99% OF GERMS

    Formulated and enhanced with Zetrisil®

    DISTRIBUTED BY:
    ESC BRANDS, LLC.
    1060 Blue Prince Road
    Bluefield, WV 24701
    www.myshield.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MY-SHIELD TOPICAL ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-025
    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:71884-025-0130 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2022
    2NDC:71884-025-0659 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2022
    3NDC:71884-025-04118 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2022
    4NDC:71884-025-08177 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/24/2022
    Labeler - Enviro Specialty Chemicals Inc (202621850)