Label: HAND SANITIZER WIPES- ethanol 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 October 29, 2020

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  • DOSAGE & ADMINISTRATION

    For Handwashing to decrease bacteria on the skin

    Apply sufficient amount to thoroughly wet all surfaces of hands
    and fingers. Rub onto hands until dry.
    Children under 6 should be supervised when using this product. For Handwashing to decrease bacteria on the skin

  • WARNINGS

    Flammable. Keep away from heat or flame.
    When using this product
    Do not use in or near the eyes. In case of contact, rinse eyes thoroughly
    with water.
    Keep out of reach of children if swallowed get medical help or contact
    a Poison Control Center right away.
    Stop use and ask a doctor if irritation or rash occurs and lasts

    warnings section

  • INACTIVE INGREDIENT

    glycerin, water

    inactive ingredients

  • INDICATIONS & USAGE

    For Handwashing to decrease bacteria on the skin

    Indications

  • 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.

    Keep out of reached of children

  • PURPOSE

    Hand sanitizing wipes - for handwashing to decrease bacteria on the skin

    Purpose

  • ACTIVE INGREDIENT

    Alcohol - 75%

    Active ingredients

  • PRINCIPAL DISPLAY PANEL

    alcoholwipepolypak.jpg

    alcoholwipepolypak.jpg 80285-129-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WIPES 
    ethanol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80285-129
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80285-129-015 in 1 BOX10/21/2020
    14 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/21/2020
    Labeler - Polypak Industries AG (224679539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Youquan Care Products Technology Co., Ltd.421318425manufacture(80285-129)
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