Label: MY-SHIELD HAND SANITIZER- benzalkonium chloride spray

  • NDC Code(s): 71884-012-00, 71884-012-01, 71884-012-02, 71884-012-07, view more
    71884-012-10, 71884-012-16, 71884-012-50
  • 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 December 22, 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.

  • Directions:

    Spray liberally on the palms of the hands.

    Rub into skin until dry. Recommended for repeat use

  • Warnings:

    Do not freeze. For external use only.

    Do not use in ears, eyes or mouth.

    • When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
    • Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    • Keep out of reach of children.
    • Children should be supervised when using this product.
  • Inactive Ingredients:

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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    FAST ACTING 15 SECOND FORMULA

    WITH SOOTHING ALOE VERA

    Alcohol-Free

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

    KILLS 99.99% OF GERMS

    Formulated and enhanced with Zetrisil

    Distributed by: ESC Brands, LLC.

    664 Old Hargraves Road - Suite B

    Lexington, NC 27295

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MY-SHIELD HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-012
    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)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-012-0010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    2NDC:71884-012-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    3NDC:71884-012-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    4NDC:71884-012-07200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    5NDC:71884-012-16473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    6NDC:71884-012-103785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
    7NDC:71884-012-5019000 mL in 1 CONTAINER; Type 0: Not a Combination Product11/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/27/2020
    Labeler - Enviro Specialty Chemicals Inc (202621850)
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