Label: MEDLINE- ethyl alcohol cloth

  • NDC Code(s): 53329-842-30, 53329-842-90, 53329-842-98
  • Packager: Medline Industries, LP
  • 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 25, 2022

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  • Active ingredient

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    • • health care personnel hand rub to help reduce bacteria that potentially can cause disease
  • 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 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.

  • 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
  • Other information

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

    glycerin, hydrogen peroxide, purified water USP

  • Manufacturing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    1-800-MEDLINE (633-5463)

    REF: HHWIPES001

    RI20HND

  • Package Label

    front

    back

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-842
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-842-981000 in 1 CASE01/01/202101/31/2022
    1NDC:53329-842-901.5 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-842-30100 in 1 BOX01/01/202101/31/2022
    2NDC:53329-842-901.5 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/31/2020
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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