Label: DISINFECTION WET WIPES patch

  • NDC Code(s): 42003-101-80
  • Packager: Zhejiang Jiayan Daily Commodity Co., Ltd
  • 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 7, 2020

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  • Active ingredient

    Phenoxyethanol, 0.5% w/w;

    Benzalkonium Chloride, 0.15% w/w.

  • Inactive ingredient

    Ethylhexylglycerin; Didecyldimonium Chloride; Propylene Glycol; Glycerin; Water.

  • Purpose

    Kill the intestinal pathogenic bacterium, staphylococcus aureus pseudomonas aeruginosa candida albicans.

  • When using

    Please close the pakage immediately after use.

    If there are obvious stains on the surface of the object, when the blood stains, should use a piece of wet towel to remove the dirty, and then take a piece of wet towel for sterilization treatment.

  • Do not use

    For external use, avoid contact with eyes and wound skin.

  • Stop use

    If you feel uncomfortable, please seek medical advice.

  • Keep out of reach of children

    The product should be kept out of reach of children.

  • Indications & usage

    Applicable to the hand skin, object surface and medical equipment surface cleaning sterilization.

  • Dosage & administration

    Open the package of wet towel and take out and unfold the wet towel.

    From one side of the surface of the object, from the top down by the s-type wipe to the entire surface, action for 3 minutes.

  • Warnings

    For external use, avoid contact with eyes and wound skin.

    This product is disposable, should follow the "one thing one towel" use principle, avoid cross contamination.

  • Other information

    Keep out of the light, sealed, and in a cool place.

  • Package label. Principal display panel

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTION WET WIPES 
    disinfection wet wipes patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42003-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 U  in 100 U
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.5 U  in 100 U
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42003-101-8080 U in 1 PACKAGE; Type 0: Not a Combination Product05/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2020
    Labeler - Zhejiang Jiayan Daily Commodity Co., Ltd (679832147)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jiayan Daily Commodity Co., Ltd679832147label(42003-101) , manufacture(42003-101)
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