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

  • NDC Code(s): 54410-001-01, 54410-001-02, 54410-001-03
  • Packager: DevMar Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.1%

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  • PURPOSE

    Purpose

    Antimicrobial

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  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

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  • 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.

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  • 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

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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • 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


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  • INGREDIENTS AND APPEARANCE
    4 SURE PLUS E3 INSTANT FOAM HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54410-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETRIMONIUM CHLORIDE  
    LAURTRIMONIUM CHLORIDE  
    DIHYDROXYETHYL COCAMINE OXIDE  
    GLYCERETH-17 COCOATE  
    CITRIC ACID MONOHYDRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54410-001-01 50 mL in 1 BOTTLE, PLASTIC
    2 NDC:54410-001-02 210 mL in 1 BOTTLE, PLASTIC
    3 NDC:54410-001-03 550 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/10/2013
    Labeler - DevMar Products LLC (809038255)
    Establishment
    Name Address ID/FEI Business Operations
    Maxpax LLC 027109390 manufacture(54410-001)
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