Label: E-2 CLEANSER SANITIZER 86- hand sanitizer soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 21, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Benzalkonium Chloride 2.5%

  • PURPOSE

    Purpose
    Food Handlers Hand Wash

  • INDICATIONS & USAGE

    Uses

    • Hand wash to help reduce bacteria that cause disease
    • Repeated usage suggested
  • WARNINGS

    Warnings

    For external use only.
    Keep out of reach of children.
    Avoid contact with eyes and mouth.
    If redness develops, discontinue use immediately. If condition persists for
    more than 72 hours, consult a physician.
    Not for use on children under 6 months of age.
  • DOSAGE & ADMINISTRATION

    Directions

    • Hands do not require washing prior to use.
    • Apply 5 mL of product to hands.
    • Scrub well for 30 seconds.
    • Rinse and repeat.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, PEG-6 Cocamide, Hydroxypropyl Methylcellulose, Quaternium-15, Citric Acid, Sodium
    Hydroxide

  • INACTIVE INGREDIENT


  • QUESTIONS

    In Case of Emergency
    Call: (800) 228-5635 ext. 167
  • PRINCIPAL DISPLAY PANEL

    Label for 500 mL bottle

  • INGREDIENTS AND APPEARANCE
    E-2 CLEANSER SANITIZER 86 
    hand sanitizer soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42497-086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Quaternium-15 (UNII: E40U03LEM0)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hypromellose (UNII: 3NXW29V3WO)  
    Product Characteristics
    Coloryellow (pale yellow to amber) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42497-086-01500 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/21/2010
    Labeler - Penco Products, Inc. (808679773)
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