Label: ZAPPY ULTIMATE ANTISEPTIC WIPES- wet wipes cloth

  • NDC Code(s): 84215-001-01
  • Packager: Freshening Paper Products（Hui Zhou）Co.Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 8, 2024

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  • Active Ingredient(s)

    Chlorhexidine digluconate ：0.100%

    Benzalkonium chloride：0.100%

  • Purpose

    Anti corrosion and antibacterial, wiping and disinfecting

  • Use

    Skin irritation is not common, but if a reaction occurs, please stop using immediately.

    Discard used wipe in trash.

    Do not flush in toilet.

    SAFE & NO RINSING .REQUIRED.

  • Warnings

    ●Avoid contact with eyes.

  • Do not use

    in children less than 2 months of age

  • 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

  • Directions

    Instruction for Use: Ready to use wipes. Wipe all areas of hands or surface tll visibly clean and air dry. Use a new wipe for a new surface.

  • Other information

    Nothing

  • Inactive ingredients

    Purified water, Phenoxyethanol, Sodium gluconate, Fragrance, Benzalkonium chloride (0.10%W/v), Chlorhexidine digluconate (0.10%W/v), Polyaminopropyl biguanide, Ethylhexylglycerin, Polysorbate 20, Tocopheryl acetate

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    ZAPPY ULTIMATE ANTISEPTIC WIPES 
    wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84215-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.1 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84215-001-0150 in 1 BAG; Type 0: Not a Combination Product04/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/08/2024
    Labeler - Freshening Paper Products（Hui Zhou）Co.Ltd (723246894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Freshening Paper Products（Hui Zhou）Co.Ltd723246894manufacture(84215-001)
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