Label: GERM FREE ZONE SANITIZING WIPE- alcohol cloth

  • 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 June 1, 2017

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 70% (v/v)

  • Purpose

    Antimicrobia

  • Uses:

    Helps reduce becteria, fungl, and some viruses.

  • WARNINGS

    For external use only.

    • Flammable, keep away from heat and flame.
    • Do not use in or near eyes. If eye contact occurs flush thoroughly with water and seek medical care.
    • Avoid contact with broken skin.
    • Stop use and seek medical attention if irritation and redness occurs.
    • Ingestion may cause alcohol poisoning, if ingested contact a physician or local poison control center.

    Keep out of reach of children.

    In case of accidental ingestion, seekprofessional assistance or contact a Poison Control Center immediately.

  • Directions:

    • Tear open packet, wipe, discard.
  • Inactive Ingredients:

    purified water, Glycerol

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    GERM FREE ZONE SANITIZING WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71089-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) ALCOHOL.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71089-001-011 in 1 PACKAGE06/01/2017
    13.0 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2017
    Labeler - Germ Guards Incorporated (080329404)