Label: INSTANT HAND SANITIZER- alcohol gel

  • 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 July 20, 2011

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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 65%

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses •to decrease bacteria on the skin that could cause disease  •recommended for repeated use
  • WARNINGS

    Warnings
    For external use only-hands

    Flammable.  Keep away from heat and flame

    When using this product
    •keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
    •do not inhale or ingest
    •avoid contact with broken skin

    Stop use and ask a doctor if skin irritation develops

    Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately
  • DOSAGE & ADMINISTRATION

    Directions
    •wet hands thoroughly with product and allow to dry without wiping
    •for children under 6, use only under adult supervision
    •not recommended for infants
  • STORAGE AND HANDLING

    Other information •do not store above 105⁰F  •may discolor some fabrics  •harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Inactive ingredients benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water
  • GENERAL PRECAUTIONS

    Effective at eliminating over 99.99% of many common harmful germs and bacteria in as little as 15 seconds.
    Made in USA with US and foreign components.
    SDA-MO-15036 SDA-WI-2059 SDA WI-2486 DSP-MO-28 DSP-MO-34
  • ADVERSE REACTIONS

    We welcome your questions and comments.
    Call: 1-800-ShopRite (8am-8pm EST) E-mail: www.shoprite.com
    Write: Wakefern Food Corp. Consumer Affairs -P7-103
    600 York St. Elizabeth, NJ 07207
    Please provide product UPC and code stamped on product.
    DISTRIBUTED BY
    WAKEFERN FOOD CORPORATION
    5000 RIVERSIDE DRIVE
    KEASBEY, NJ 08832
  • PRINCIPAL DISPLAY PANEL

    ShopRite
    INSTANT
    Hand
    Sanitizer
    •with Moisturizers•
    + Vitamin E
    Kills 99.99% of Germs
    without Water
    32 FL OZ (946 mL)
    image of principal display panel


  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41190-951-16.059 L in 1 BOTTLE, PLASTIC
    2NDC:41190-951-34.236 L in 1 BOTTLE, PUMP
    3NDC:41190-951-45.946 L in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2011
    Labeler - WakeFern Food Corporation (069722418)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture
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