Label: SANIKLEAN E3 HAND SANITIZER- alcohol liquid

  • 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 December 5, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients

    Ethyl Alcohol 70% (v/v)

  • PURPOSE

    Purpose

    Hand Sanitizer

  • INDICATIONS & USAGE

    Uses

    Hand wash to help reduce bacteria that potentially can cause diseases

    Helps prevent cross contamination by hand contact

    Helps prevent drying and chafing of skin

    Recommended for repeated use

  • WARNINGS

    Warnings

    For External use only

    Flammable, keep away from fire or flame


    When using this product

    Do not use in or near eyes

    Use in well-ventilated area

    Discontinue use if irritation and/or redness develops

    Keep out of reach of children.

    In case of accidental ingestion, seek medical attention or contact Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands thoroughly with product, covering entire surface of hands, including fingertips, cuticles, wrists and forearms

    Rub vigorously into skin until dry

    No rinsing or toweling required

  • STORAGE AND HANDLING

    Store in a cool dry place below 104 F

    For Food Processing, Food Service and Professional Use Only

    NDC 21532-1410-1

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Glycerin

  • PRINCIPAL DISPLAY PANEL

    SaniKleen

    E3 Hand Sanitizer

    Marketed By:

    Bunzl

    528 East 19th Avenue

    North Kansas City, MO 64116

    CONTENTS: 1 Gallon

    container label


  • INGREDIENTS AND APPEARANCE
    SANIKLEAN E3 HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21532-1410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21532-1410-13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2006
    Labeler - Bunzl Processor Distribution LLC (007169634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(21532-1410)
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