Label: F MATIC ALCOHOL BASED HAND SANITIZER- alcohol liquid

  • 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 18, 2020

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  • Drug Facts

  • Active Ingredient:

    Ethyl Alcohol 62%

    Antiseptic

  • Indications:

    for hand-washing to decrease bacteria on the skin, only when water is not available.

  • Warnings:

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

    When using this product

    • do not get into eyes
    • if contact occurs, rinse eyes thoroughly with water

    Stop use and ask doctor if

    irritation and redness develop

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place a palmful in one hand. Spread onto both hands to wrist and rub into the skin until dry.
    • Use when soap and water are not available, or to supplement hand washing.
  • Inactive Ingredients:

    Water, Glycerol, Hydrogen Peroxide.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    F MATIC ALCOHOL BASED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77347-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77347-001-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - F-Matic, Inc. (108393349)
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