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 December 2, 2009

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin without soap and water
    • 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 thoroughly 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 GERMS TRAVEL, LLC

    Voorhees, NJ 08043 • 877-422-2928 • www.GermsTravel.com

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH

    Instant Hand Sanitizer

    Kills 99.99% of germs

    Enriched with Aloe Vera

    www.GermsTravel.com

    0.125 FL. OZ (3.7 ML)

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50167-7100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.60 g
    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:50167-7100-11000 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33312/02/2009
    Labeler - Germs Travel, LLC (832413913)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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