Label: ANTISEPTIC FORMULA FILLED SWAB - lidocaine hydrochloride and benzalkonium chloride liquid

  • NDC Code(s): 65734-270-00, 65734-270-72
  • Packager: Swabplus 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 03/13

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

  • Active ingredients

    Benzalkonium Chloride 0.11%

    Lidocaine Hydrochloride 1.0%

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  • Purpose

    Benzalkonium Chloride    for Antiseptic

    Lidocaine Hydrochloride   for Pain relief

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  • Uses

    Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.

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  • Keep out of reach of children

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

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  • Directions

    • Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other.
    • Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
    • Apply the product to the affected area.
    • Discard swab after use.
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  • Warnings

    • For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
    • Do not use. longer than one week unless directed  by a doctor.
    • Stop use and ask a doctor if you have deep or puncture wounds, or serious burns, redness, irritation, swelling or pain continues or increase, infection occurs.
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  • Administration

    • For adult and children 2 and older:Clean affected area and apply 1 to 3 times daily. May be covered with a bandage.
    • Children under 2 years of age: Do not use, consult a doctor. 
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  • Other information

    Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.

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  • Inactive ingredients

    Dizolidinyl Urea, Methylparaben, Propylparben, water.

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  • Patent

    Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 Made in USA

    The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

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  • Package and Label

    Image of antiseptic carton label

    Image of antiseptic carton label

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC FORMULA FILLED SWAB  
    lidocaine hydrochloride, benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65734-270
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lidocaine Hydrochloride (Lidocaine) LIDOCAINE HYDROCHLORIDE ANHYDROUS 100 mg  in 10 mL
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 11 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    DIAZOLIDINYL UREA  
    Methylparaben  
    Propylparaben  
    Propylene Glycol  
    Product Characteristics
    Color white (Colorless) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65734-270-72 72 in 1 PACKET
    1 NDC:65734-270-00 0.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc (876441549)
    Establishment
    Name Address ID/FEI Business Operations
    Swabplus Inc 876441549 manufacture(65734-270), relabel(65734-270), repack(65734-270)
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