Label: HAND WIPES- benzalkonium chloride swab

  • NDC Code(s): 71734-303-01
  • 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 June 5, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Benzalkonium Chloride .......... 0.13 %

  • Purpose

    Antiseptic

  • Uses:

    Cleans and refreshes hands and face without soap and water.

  • WARNINGS

    Warnings

    For external use on hands only. Stop use and ask a doctor if irritation develops.

    Store and handling

    Store in a cool place.

    Keep out of reach of children.

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

  • Directions

    Self-dries in seconds. Leave skin soft and smooth.

  • Inactive Ingredients:

    Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    HAND WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) benzalkonium chloride0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    CLONITRATE (UNII: MIG1YFL8MD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-303-019 g in 1 PACKAGE; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/05/2020
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-303)
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