Label: 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 August 1, 2013

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  • Active Ingredients

    Benzalkonium Chloride  0.12%

    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 dondition 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.

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

  • Inactive Ingredient

    None

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BANDAGE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59229-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0012 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    COTTON FIBER (UNII: 70LDW53ROO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59229-003-0236 in 1 CARTON
    140 in 1 BOX
    10.0459 mg in 1 POUCH
    2NDC:59229-003-0124 in 1 CARTON
    240 in 1 BOX
    20.0459 mg in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2013
    Labeler - YUYAO CHENGZE MEDICAL SUPPLIES FACTORY (421319456)
    Establishment
    NameAddressID/FEIBusiness Operations
    YUYAO CHENGZE MEDICAL SUPPLIES FACTORY421319456manufacture(59229-003)