MY SHIELD SANITIZING BATH (BENZALKONIUM CHLORIDE) SWAB [ESC BRANDS LLC]

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MY SHIELD SANITIZING BATH (BENZALKONIUM CHLORIDE) SWAB [ESC BRANDS LLC]
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NDC 71884-004-01
Set ID 4c20af86-8642-434b-8407-ccd61632cfe4
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/Body Wash & Sanitizer

  • Uses:

    Sanitizing bath wipes to clean, deodorize & decrease bacteria from the entire body - Recommended for single 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 develop and persist for more than 72 hours.

    Keep out of reach of children.

    • Be careful not to over heat
    • Children should be supervised when using this product.

  • Directions:

    Microwave for 30 seconds on medium, remove from packaging while warm, commence to wipe over the skin and wash the body to remove grime, odors and bacteria, dispose of used wipe in an approved manner.

  • Inactive Ingredients:

    1-Octadecanaminium NN dimethyl (3-trimethoxysilyl) propyl chloride, -Octadecanaminium NN dimethyl (3-trihydroxysilyl) propyl chloride, Aloe Barbadenis leaf extract, Aqua, Caprylyl Glucoside, Citric Acid, Laureth-4, Methyl Parabens, Polyaminopropyl biguanide, Silk Protein.

  • Questions?

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

  • Package Labeling:

    Label3Label4

  • INGREDIENTS AND APPEARANCE
    MY SHIELD SANITIZING BATH 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71884-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURETH-4 (UNII: 6HQ855798J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71884-004-0148 g in 1 PACKET; 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(71884-004)
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