Label: PFA ANTIBACTERIAL WIPES- benzalkonium chloride 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 November 4, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.06%

  • INACTIVE INGREDIENTS

    Sodium Levulinate, Levulic Acid, Laurylpyridium Chloride, Sodium Coco PG-dimonium Chloride Phosphate, Caprylhydroxamic Acid, Methylpropanediol, Water

  • PURPOSE

    Antibacterial

  • WARNINGS

    For external use only.
    --------------------------------------------------------------------------------------------------------
    When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water
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    Stop use and ask a doctor if irritation and redness develops and persists.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Use(s)

    ■ For hand sanitizing to decrease bacteria on the skin.
    ■ Recommeded for repeated use.

  • Directions

    ■ Take wipe from pouch & rub thoroughly over all surfaces of both hands.
    ■ Rub hands together briskly to dry.
    ■ Dispose of wipe

  • Other information

    ■ Store below 110℉(43℃)
    ■ May discolor certain fabrics or surfaces.

  • NDC: 81787-015-01PFA ANTIBACTERIAL WIPES5.5in x 5.9in (14cm x 15cm)

    Image of packet

  • NDC: 81787-015-02PFA ANTIBACTERIAL WIPES5.5in x 7.8in (14cm x 20cm)

    Image of packet

  • INGREDIENTS AND APPEARANCE
    PFA ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81787-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium chloride0.0006 
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Levulinate (UNII: VK44E1MQU8)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81787-015-0110 in 1 PACKET; Type 0: Not a Combination Product10/01/2021
    2NDC:81787-015-0210 in 1 PACKET; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2021
    Labeler - Korea Living Goods Lab (695538788)
    Registrant - Korea Living Goods Lab (695538788)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Living Goods Lab695538788manufacture(81787-015)
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