Label: FRESHNAP PLUS - 80% ETHYL ALCOHOL TOWELETTE- alcohol towelette 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 January 1, 2023

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 80% (v/v)

    Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reduce bacteria on the skin.
  • Warnings

    • Flammable. Keep away from heat or flame.
    • For external use only. Avoid contact with eyes, ears and mouth. In case of eye contact, flush with water.

    Stop using and ask a doctor if

    • skin irritation or redness develops.

    Keep out of reach of children

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

    Do Not Use

    • Children under 2 months old or open wounds
  • Directions

    • Unfold towelette, wipe hands thoroughly and discard.
  • Inactive ingredients

    Denatonium Benzoate, Glycerin, Hydrogen Peroxide, Aqua (Water)

  • Package Labeling:

    Freshnap Plus - 80% Ethyl Alcohol Towelette (Back)Freshnap Plus - 80% Ethyl Alcohol Towelette (Front)

  • INGREDIENTS AND APPEARANCE
    FRESHNAP PLUS - 80% ETHYL ALCOHOL TOWELETTE 
    alcohol towelette cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79985-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79985-200-011 in 1 PACKAGE01/01/2023
    15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2023
    Labeler - KARI-OUT LLC (012186557)
    Registrant - KARI-OUT LLC (012186557)
    Establishment
    NameAddressID/FEIBusiness Operations
    KARI-OUT LLC012186557manufacture(79985-200)
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