Label: HAND SANITIZER- alcohol gel

  • 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 November 14, 2012

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  • Active ingredient

    Active ingredient

    Ethyl alcohol 70%

  • purpose

    Purpose

    Antiseptic

  • Uses

    Uses

    • to decrease bacteria on the skin that could cause disease
    • recommend for repeated use
  • Warnings

    Warnings

    For external use only-hands

  • Flammable

    Flammable. Keep away from heat and flame

  • When using

    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

    Stop use and ask a doctor if skin irritation develops

  • Keep out of reach of children

    Keep out of reach of children. If swallowed get nedical help or contact a Poison Control Center right away

  • Directions

    Directions

    • wet hands thoroghly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    Other information

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

    Inactive ingredients water glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

  • Claims

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

  • Disclaimer

    This product is no manufactured or distributed by GOJO Industries, Inc., distributor of Purell refreshing Gel Advanced Hand Sanitizer

  • Adverse Reactions Section

    DISTRIBUTED BY: CARDINAL HEALTH, DUBLIN, OHIO 43017

    www.myleader.com

  • Principal Display Panel

    NDC 37205-733-34

    LEADER

    More

    Effective

    Formula

    Compare to Purell

    Advanced

    Hand

    Sanitizer

    Kills more than 99.99% of germs

    8 FL OZ (236 mL)

    image description

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-733
    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)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-733-34236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/09/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(37205-733)
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