HAND SANITIZER (ETHYL ALCOHOL) GEL [STERIS CORPORATION]

HAND SANITIZER (ETHYL ALCOHOL) GEL [STERIS CORPORATION]
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NDC 0519-8802-13, 0519-8802-41
Set ID a300801d-2c3a-4d94-98e2-88ed50a2100e
Category HUMAN OTC DRUG LABEL
Packager Steris Corporation
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    Healthcare Personnel Handwash to decrease bacteria on the skin before contact with patients under medical care or treatment

  • Warnings

    For external use only-hands

    Keep away from heat and flame

  • When using this product

    • keep out of eyes.  In case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest
  • Stop use and ask a doctor if

    skin irritation develops.  If condition persists more than 72 hours consult a doctor.

  • Keep out of reach of children.

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

  • Directions

    wet hands thoroughly with product and allow to dry without wiping

  • Other information

    • do not store above 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

  • Questions or Comments

    800-548-4873

  • SPL UNCLASSIFIED SECTION

    Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds*

    Soft' N Sure is a registered trademark of STERIS Corporation. Dignity Health and its logo are tradmarks of Dignity Health

    Manufactured for:

    STERIS Corporation

    7501 Page Avenue

    St. Louis, MO 63133 USA

    800-548-4873   www.steris.com

  • principal display panel

    NDC 0519-8802-13

    Dignity Health Hand Sanitizer Soft N SureAntiseptic Hand Gel

    Moisturizing Fast Acting

    8D02-26

    For Hospital and Professional use Only

    6542

    8D02-XEA (F) (814)

    NET CONTENTS: 444 mL (15 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-8802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL578 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    glycerin (UNII: PDC6A3C0OX)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0519-8802-13444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2014
    2NDC:0519-8802-411000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/08/2014
    Labeler - Steris Corporation (139424188)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0519-8802)

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