Label: ALCOHOL ANTISEPTIC 80- 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 May 12, 2020

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  • Drug Facts

  • Active Ingredient:

    Alcohol 80% v/v

    Purpose:

    Antiseptic

  • Use(s):

    Hand sanitizer to help reduce the bacteria that potentially will cause disease

  • Warnings:

    For External Use Only
    Flammable keep away from children

    When using this product:

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop and ask a doctor if:

    If irration or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children:

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

  • Directions:

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing

  • Inactive Ingredients:

    Glycerin, Hydrogen peroxide, purified water USP

  • Packaeg Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC 80 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77188-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77188-000-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/11/2020
    Labeler - Resource One Inc (081366510)
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