Label: MYKRO MAX ANTIBACTERIAL WIPES- benzalkonium chloride swab

  • NDC Code(s): 71734-330-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES 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 October 6, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Benzalkonium Chloride .......... 0.1212 %

  • Purpose

    Antiseptic

  • Uses:

    • Sanitizing wipe to help reduce bacteria that potentially can cause disease.
    • For use when soap and water are not available.
    • Safe for repeated use.
  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with eyes .If contact occurts ,flush thoroughly with water.

    Discontinue use if irritation or redness develops . If conditon persists for more than 72 hours contact a doctor.

    Do not use as a diaper wipe.

    Keep out of reach of children.

    if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Cover all surfaces thoroughly with wipe and allow to dry naturally .Supervise children under 6 years of age to avoid putting product in mouth.

  • Inactive Ingredients:

    Dimethyl Diallyl Ammonium Chloride, Didecyldimethylammonium Chloride, Purified Water，Lemon Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    MYKRO MAX ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) benzalkonium chloride0.1212 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DIMETHYL DIALLYL AMMONIUM CHLORIDE (UNII: 8MC08B895B)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-330-01100 in 1 CANISTER10/06/2020
    13.25 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2020
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-330)
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