Label: 75% ALCOHOL WIPES- disinfection wet wipes patch

  • 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 19, 2020

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  • Active ingredient

    Ethanol Alcohol, 75% v/v, antiseptic

  • Inactive ingredient

    Water

  • Purpose

    Daily Clean for daily items and Antimicrobial.

  • When using

    This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • Stop use

    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.

  • Indications & usage

    This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

    Open the label, take out the wet towel and wipe the target area.

  • Dosage & administration

    Use it as needed, after following the usage instructions.

    For external use only.

  • Warnings

    Do not apply this product to red and swollen skin, wound or any part sensitive to it.

    Keep this product out of children’s reach in case they might eat it.
    Alcohol is violatile, please use it as soon as possible after opening, store it in a cool and dry place, avoid direct sunlight and open fire, and avoid contact with eyes and damaged skin.

  • Package label. Principal display panel

    88

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    disinfection wet wipes patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75163-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75163-100-1010 U in 1 PACKAGE; Type 0: Not a Combination Product04/21/2020
    2NDC:75163-100-011 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    3NDC:75163-100-1220 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    4NDC:75163-100-1430 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    5NDC:75163-100-1640 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    6NDC:75163-100-2050 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    7NDC:75163-100-2260 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    8NDC:75163-100-2680 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    9NDC:75163-100-30100 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    10NDC:75163-100-36160 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/21/2020
    Labeler - Zhuji Jianhe Paper Co., Ltd (554529241)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhuji Jianhe Paper Co., Ltd554529241label(75163-100) , manufacture(75163-100)
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