Label: AIWEIER ALCOHOL WIPES- wipes cloth

  • NDC Code(s): 55490-004-01
  • Packager: Baijieyuan Biotechnology (Shandong) 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 June 10, 2020

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  • DOSAGE & ADMINISTRATION

    Store below 110°F (43°C)

  • INACTIVE INGREDIENT

    Butane-1,3-diol

    Glycerol

    Aloe extract

    Pure water

  • INDICATIONS & USAGE

    Open the upper cover, cpen the unsealing glue, pull out the wet wipes,and dose the upper cover tightly to prevent the wet wipes from drying.

  • ACTIVE INGREDIENT

    Bronopol

    Benzethonium chloride

    2-Phenoxyethanol

    Quaternary ammonium compounds,benzyl-C12-16-alkyldimethyl,chlorides

    Ethyl alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only,Keep away from heat or flame.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AIWEIER ALCOHOL WIPES 
    wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55490-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRONOPOL (UNII: 6PU1E16C9W) (BRONOPOL - UNII:6PU1E16C9W) BRONOPOL0.0969 g  in 20 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0969 g  in 20 
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL242.25 g  in 20 
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.0646 g  in 20 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.1938 g  in 20 
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55490-004-0120 in 1 PACKET; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - Baijieyuan Biotechnology (Shandong) Co., Ltd. (554531114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baijieyuan Biotechnology (Shandong) Co., Ltd.554531114manufacture(55490-004)
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