Label: SANITIZING WET WIPES- alkyl dimethyl benzyl ammonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Sanitizing Wet Wipes

  • Active Ingredient(s)

    Alkyl dimethyl benzyl ammonium chloride, 0.224mg/pcs
    Dioctyl dimethyl ammonium chloride, 0.168mg/pcs
    Didecyl dimethyl ammonium chloride, 0.07mg/pcs
    Octyl decyl dimethyl ammonium chloride, 0.1mg/pcs

  • Purpose

    Antiseptic, Sanitizing Wet Wipes

  • Use

    Sanitizing Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wipe the surface of the skin and let it air dry
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Glycerin
    2-Bromo-2-Nitropropane-1
    IPBC
    PHMB(Polyaminopropyl Biguanide)
    Aloe Barbadensis Leaf Extract
    Vitamin E

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    SANITIZING WET WIPES 
    alkyl dimethyl benzyl ammonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80337-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    QUATERNIUM-24 (UNII: 0T2NG1539G) (QUATERNIUM-24 - UNII:0T2NG1539G) QUATERNIUM-240.1 mg
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.224 mg
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.07 mg
    Inactive Ingredients
    Ingredient NameStrength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIOCTYLDIMONIUM CHLORIDE (UNII: 0X0RL40Y6H) 0.168 mg
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80337-201-0180 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Jiangsu Xiaolikang Medical Technology Co., Ltd. (554546867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Xiaolikang Medical Technology Co., Ltd.554546867manufacture(80337-201)
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