MY-SHIELD SANITIZING (BENZALKONIUM CHLORIDE) LIQUID [ESC BRANDS LLC]

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MY-SHIELD SANITIZING (BENZALKONIUM CHLORIDE) LIQUID [ESC BRANDS LLC]
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NDC 71884-003-08
Set ID 8858dcba-92d5-4895-ac07-dd73185d1094
Category HUMAN OTC DRUG LABEL
Packager ESC Brands LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose:

    Antiseptic Hand Soap

  • Uses

    • Handwash to help reduce bacteria that potentially can cause disease • Helps to prevent crosscontamination by hand contact • Helps to prevent drying of skin • Recommended for repeat use

  • Warnings

    For external use only.

    When using this product

    do not use in or near eyes.

    Stop use and ask doctor if

    irritation and redness develop.

    Keep out of reach of children.

    If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • Directions

    • Wet Hands and wrists with clean running water • Apply appropriate amount of product • Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly • Rinse thoroughly with running water • Dry hands completely (incomplete drying may result in chapped skin)

  • Other Information

    Store in a cool dry place below 104° F (40°C)

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Aqua, Benzyl Alcohol, Citric Acid, Glycerin, Hydrolysed Silk, Lauramidopropyl Betaine, Phenoxyethanol.

  • Questions?

    +1 (336) 655 2219 Mon-Fri 9:00AM-5:00PM (EST)

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    MY-SHIELD SANITIZING 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-003
    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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-003-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/201812/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/201812/31/2021
    Labeler - ESC Brands LLC (202621850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(71884-003)
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