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
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

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

  • Active Ingredients

    Benzalkonium chloride, 0.13% v/v

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  • Purpose

    First Aid Antiseptic

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  • Uses

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

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  • 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.

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  • 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.
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  • Other Information

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

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  • Inactive Ingredients

    Purified water

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  • Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL

    Place holder text

    image of outer box container label

    image of individual packet label

    image of swabsticks label

    image of individual sterilizable packet label

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  • INGREDIENTS AND APPEARANCE
    LORIS BZK  ANTISEPTIC WIPES
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68356-126
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68356-126-01 100 in 1 BOX
    1 NDC:68356-126-02 2.6 g in 1 PACKET
    2 NDC:68356-126-04 2.6 g in 1 PACKET
    3 NDC:68356-126-03 3 in 1 PACKAGE
    3 2.5 g in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/21/2012
    Labeler - LernaPharm Loris Inc. (206940905)
    Establishment
    Name Address ID/FEI Business Operations
    LernaPharm Loris Inc. 206940905 manufacture(68356-126), label(68356-126)
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