Label: INSTANT HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 9, 2009

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Pupose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin
    • recommended for repeated use
  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    Do not use in the eyes. If this happens, rinse thoroughly with water

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

  • Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thorough with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

    Manufactured for Graphic Controls LLC
    Buffalo, NY 14204
    1-800-669-1535

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE

    FREE Sample-Not for Resale

    GRAPHIC CONTROLS LLC – Instant Hand Sanitizer

    For more information or To Order call

    800-665-1535

    www.graphiccontrols.com

    Kills 99.99% of Germs

    Enriched with Aloe Vera

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49959-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.60 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49959-1111-059 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33311/30/2009
    Labeler - Graphic Controls (002111896)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE
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