Label: ANTIBACTERIAL BANDAGE- benzalkonium chloride swab

  • 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 September 23, 2014

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  • Active Ingredients

    Benzalkonium Chloride  1 %

    Purpose

    Antiseptic

  • Use

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

  • Warnings

    For external use only.

    Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

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

  • Directions

    Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

  • Inactive Ingredient

    None

    Other information: Not intended for use on delicate or sensitive skin.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BANDAGE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-313-3030 in 1 BOX
    10.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2014
    Labeler - International Wholesale, Inc. (161872676)
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