Label: LORIS BZK ANTISEPTIC WIPES- benzalkonium chloride swab

  • NDC Code(s): 68356-126-01, 68356-126-02, 68356-126-03, 68356-126-04
  • Packager: LernaPharm Loris Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Benzalkonium chloride, 0.13% v/v

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

  • Warnings

    For External Use Only

    • Do not use in the eyes or apply over large areas of the body.
    • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
    • Stop use and consult a doctor if the condition persists or gets worse.
    • Do not use for longer than 1 week unless directed by a doctor.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Tear open pouch and use as part of your daily cleansing routine.
    • Clean the affected area.
    • Apply this product on the area 1 to 3 times daily.
    • May be covered with a sterile bandage.
    • If bandaged, let dry first.
  • Other Information

    Store at room temperature between 59-86 oF (15-30 oC). If contact with eyes occurs, flush eyes with water.

  • Inactive Ingredients

    Purified water

  • Questions or comments?

    Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

  • PRINCIPAL DISPLAY PANEL

    Place holder text

    image of 100-count outer box container label

    image of individual packet label

    image of swabsticks label

    image of individual sterilizable packet label

  • INGREDIENTS AND APPEARANCE
    LORIS BZK  ANTISEPTIC WIPES
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68356-126
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68356-126-022.6 g in 1 PACKET; Type 0: Not a Combination Product11/21/2012
    2NDC:68356-126-042.6 g in 1 PACKET; Type 0: Not a Combination Product11/21/2012
    3NDC:68356-126-01100 in 1 BOX11/21/2012
    32.6 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:68356-126-033 in 1 PACKAGE11/21/2012
    42.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/21/2012
    Labeler - LernaPharm Loris Inc. (206940905)
    Establishment
    NameAddressID/FEIBusiness Operations
    LernaPharm Loris Inc.206940905manufacture(68356-126) , label(68356-126)