Label: ANTIMICROBIAL HAND WIPE- alcohol cloth

  • 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 18, 2009

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin when soap and water is not available
  • Warnings

    For external use only

    Flammable: keep away form fire or flame

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

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

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

  • Directions

    • tear open packet, remove towelette
    • wipe hand/wrist areas for 15 seconds and discard
    • supervise children under 6 years of age

    Inactive ingredients aloe vera, fragrance, purified water, triethanolamine

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH

    FLU SHIELD ANTIMICROBIAL HAND WIPES

    Kills 99.99% of germs

    1 premoistened towelette

    For Professional Use

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – POUCH
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65460-3111
    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)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (WHITE) Score    
    ShapeRECTANGLE (RECTANGLE) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65460-3111-11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33311/30/2009
    Labeler - SAS Safety (122036627)
    Registrant - Safetec (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE
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