Label: HAND SANITIZER- ethanol 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 September 5, 2011

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  • Drug Facts

    Active Ingredient

    Ethyl alcohol 60%

    Purpose

    Antimicrobial

    Uses

    for hand sanitizing to decrease bacteria on the skin when soap and water are not available.

    Warnings

    For external use only-hands.

    When using this product

    avoid contact with eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if

    irritation or redness develops.

    Keep out of reach of children.

    If swallowed, drink plenty of water & consult a physician or Poison Control Center immediately.

    Other information

    • do not store above 105°F.
    • may discolor some fabrics.
    • harmful to wood finishes and plastics.

    Directions

    • pour a small amount of gel onto palm of hand. Rub briskly over all surfaces of both hands until dry.
    • children under 6 should be supervised while using this product. Not recommended for infants.

    Inactive Ingredients

    carbomer, fragrance, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water/aqua

  • SPL UNCLASSIFIED SECTION

    *Effective at eliminating over 99.99% of many common household germs & bacteria in as little as 15 seconds.

    Distributed by: Just Play
    Deerfield Beach, FL
    1-800-317-3245

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • Principal Display Panel – Bottle Label

    HAND SANITIZER
    LIGHT CITRUS SCENT

    Kills 99.99% of Germs*
    1.7 FL OZ (50 mL)

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76308-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76308-001-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/05/2011
    Labeler - Just Play, LLC (961720922)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kingkey Daily Chemical Co., Ltd.545349263MANUFACTURE
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