Label: ANTISEPTIC TOWELETTES- 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 December 27, 2017

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  • Drug Facts

  • Active Ingredients

    Benzalkonium chloride .4%

  • Purpose Section

    Antiseptic

  • Uses

    Antiseptic to help prevent the risk of infection

  • Warning

    For External Use Only

  • Do Not

    use in the eyes

    use as a first aid antiseptic longer than 1 week

    apply over large areas of the body

  • Stop Use

    if the condition persists or gets worse

  • Ask a doctor in case of

    deep or puncture wounds, animal bites, or serious burns

  • Keep out of reach of children section

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Clean the affected area

    apply a small amount of the product on the area

    may be covered with a sterile bandage

    if bandaged let dry first

  • Other information

    store at room temperature 20-25C (68-77 F)

  • Inactive Ingredients

    Sodium bicarbonate, water

  • PRINCIPAL DISPLAY PANEL

    u1-28.jpg

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC TOWELETTES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68183-120-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/22/2015
    Labeler - Custom Kits Company Inc (928643712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynarex Corporation008124539manufacture(68183-120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Kits Company Inc928643712repack(68183-120) , relabel(68183-120)
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