Label: 4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 13, 2013

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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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