Label: DISINFECTANT 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 May 21, 2020

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  • DOSAGE & ADMINISTRATION

    stored in a cool and sealed place.

  • INDICATIONS & USAGE

    Open the cover whenusing, tear of the adhesive tape, can be exracteduse. use Afer, please fimely reduce the adhesive paste and close the cover to avoid inemal moisure eaporation.

  • INACTIVE INGREDIENT

    2-methyl-4-isothiazolin-3-one hydrochloride

    2-phenoxyethanol

    1,2-propanediol

    water

    Didecyl dimethyl ammonium chloride

  • ACTIVE INGREDIENT

    Benzalkonium chloride

    Alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1. This product is only for daily use and should be stored in a cool and sealed place.
    2. For extemal use only. If you find any skin discomfort or sensitivity, please stop using immediately.
    3. wipe the entryable items to be used after vlatilization;
    4. This product cannot be dissolved. Please do not throw it into the toilt.
    5. Iflammables, do not go near the source of fire.

  • PRINCIPAL DISPLAY PANEL

    010302

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT WIPES 
    disinfectant wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41382-003
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.7 mL  in 10 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.925 g  in 10 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    2-METHYL-4-ISOTHIAZOLIN-3-ONE HYDROCHLORIDE (UNII: 3G9PNZ5P41)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code Doobei
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41382-003-0110 in 1 BAG; Type 0: Not a Combination Product05/21/2020
    2NDC:41382-003-0220 in 1 BAG; Type 0: Not a Combination Product05/21/2020
    3NDC:41382-003-0350 in 1 BAG; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2020
    Labeler - Jinhua Dubei Maternal & Infant Products Co., Ltd. (413823715)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinhua Dubei Maternal & Infant Products Co., Ltd.413823715manufacture(41382-003)
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