Label: ANTIBACTERIAL WET WIPES 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 August 4, 2020

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    keep away from heat source, store in a cool and dry place, and avoid direct sunlight.

  • INACTIVE INGREDIENT

    Phenoxyethanol,Ethylhexylglycerin.Propylene Glycol.Purified Water

  • INDICATIONS & USAGE

    Open the adhesive, take out the wipes,Wipe back and forth.

  • ACTIVE INGREDIENT

    Ethanol

    Benzalkonium Chloride

    Didecyldimonium Chloride

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    Please keep the wipes out of reach of children to avoid misuse. This is an insoluble product. Do not throw it into the toilet to avoid blockage.

  • PRINCIPAL DISPLAY PANEL

    56076-004-01 10WIPES56076-004-02 1 WIPE

    20WIPES40WIPES50WIPES72WIPES80WIPES100WIPES

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    antibacterial wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56076-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL14.175 g  in 10 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.042 g  in 10 
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.0567 g  in 10 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56076-004-0110 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    2NDC:56076-004-021 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    3NDC:56076-004-0320 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    4NDC:56076-004-0440 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    5NDC:56076-004-0550 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    6NDC:56076-004-0672 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    7NDC:56076-004-0780 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    8NDC:56076-004-08100 in 1 BAG; Type 0: Not a Combination Product07/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/28/2020
    Labeler - Hangzhou Linan Poem Clean Day Co., Ltd. (560769487)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Linan Poem Clean Day Co., Ltd.560769487manufacture(56076-004)