Label: 75% ALCOHOL ANTISEPTIC 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 May 11, 2020

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  • Active Ingredient(s)

    Ethanol Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

  • Use

    Antiseptic Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation 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.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Antiseptic Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Benzethonium chloride, IPBC

  • Package Label - Principal Display Panel

    363 mL NDC: 74624-239-60 - Antiseptic Wipes 60 Each 363 mL NDC: 74624-239-60 - Antiseptic Wipes 60 Each

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL ANTISEPTIC WIPE 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74624-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.001 mL  in 100 mL
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.001 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 24.998 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74624-239-60363 mL in 1 PACKAGE; Type 0: Not a Combination Product05/05/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/05/2020
    Labeler - Total Import Solutions, Inc. (848620733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Total Import Solutions, Inc.848620733manufacture(74624-239)
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