Label: CUT CARE BENZALKONIUM CHLORIDE ANTISEPTIC- benzalkonium chloride swab 

  • NDC Code(s): 53439-130-01, 53439-130-10
  • Packager: Zeus Medical Holdings LLC
  • 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 09/13

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  • Active Ingredient

    Benzalkonium Chloride 0.13% v/v

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  • Purpose

    Antiseptic

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  • Uses

    First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns

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  • Warnings

    For external use only.

    Do not use

    • as a first aid antiseptic for more than 1 week
    • in the eyes
    • over large areas of the body

    Ask a doctor before use

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use if

    • irritation and redness develop
    • if condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children

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

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  • Directions

    • clean affected area
    • apply 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged let dry first
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  • Inactive ingredient

    purified water

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  • PRINCIPAL DISPLAY PANEL

    NDC 53439-130-10
    Cut Care
    Benzalkonium Chloride Antiseptic Towelette
    First aid antiseptic
    Contents: 100 Towelettes

    PRINCIPAL DISPLAY PANEL
NDC 53439-130-10
Cut Care
Benzalkonium Chloride Antiseptic Towelette
First aid antiseptic
Contents: 100 Towelettes

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  • INGREDIENTS AND APPEARANCE
    CUT CARE BENZALKONIUM CHLORIDE ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53439-130
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53439-130-10 100 in 1 CARTON
    1 NDC:53439-130-01 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 09/15/2013
    Labeler - Zeus Medical Holdings LLC (014884052)
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