4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [DEVMAR PRODUCTS LLC]

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  • 4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [DEVMAR PRODUCTS LLC]

4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [DEVMAR PRODUCTS LLC]
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NDC 54410-001-01, 54410-001-02, 54410-001-03
Set ID e413c4a6-c372-4ea2-801f-423b626e7504
Category HUMAN OTC DRUG LABEL
Packager DevMar Products LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Wash hands with soap and water

    Rinse with potable water

    Pump a small amount of foam into palm of hand

    Rub thoroughly over all surfaces of both hands

    Rub hands together briskly until dry

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

  • PRINCIPAL DISPLAY PANEL

    4 SURE Plus E3 Instant Foam Hand Sanitizer

    Hand Sanitizer

    Alcohol Free

    Kills up to 99.9%

    of germs on Hands

    Refreshing and Soft on Skin

    Acceptable for use in food processing facilities

    NSF

    Nonfood Compounds

    Program Listed E3

    #147444

    550 mL (18.6 fl. oz) Made in the U.S.A.

    container label


  • INGREDIENTS AND APPEARANCE
    4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54410-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54410-001-0150 mL in 1 BOTTLE, PLASTIC
    2NDC:54410-001-02210 mL in 1 BOTTLE, PLASTIC
    3NDC:54410-001-03550 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/10/2013
    Labeler - DevMar Products LLC (809038255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maxpax LLC027109390manufacture(54410-001)
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