Label: MY-SHIELD HAND SANITIZER GEL- benzalkonium chloride gel

  • NDC Code(s): 71884-011-01, 71884-011-02, 71884-011-04, 71884-011-06, view more
    71884-011-08
  • 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 May 26, 2020

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  • Drug Facts

  • Active Ingredient: 

    Benzalkonium Chloride 0.13%

  • Purpose:

    Antiseptic/Hand & Skin Sanitizer

  • Uses:

    Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.

  • 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.

    • Children should be supervised when using this product.

    • Keep out of reach of children.

  • Directions:

    Apply liberally to the palms of the hands. Rub into skin until dry. Recommended for repeat use

  • Inactive Ingredients:

    Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, 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

    WITH SOOTHING ALOE VERA

    Long lasting, alcohol-free protection from germs for your hands.

    KILLS 99.99% OF GERMS

    Formulated and enhanced with Zetrisil

    FORMULATED IN THE USA

    MADE IN CHINA

    DISTRIBUTED BY ESC BRANDS, LLC.

    664 OLD HARGRAVES ROAD - SUITE B

    LEXINGTON, NC 27295

    www.myshield.com

  • Packaging

    ESC1

    ESC2

  • INGREDIENTS AND APPEARANCE
    MY-SHIELD HAND SANITIZER GEL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    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:71884-011-013 in 1 PACKAGE05/26/2020
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71884-011-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    3NDC:71884-011-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    4NDC:71884-011-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    5NDC:71884-011-08244 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/26/2020
    Labeler - Enviro Specialty Chemicals Inc (202621850)
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