Label: CORALITE ANTIBACTERIAL BANDAGES- benzalkonium chloride swab

  • NDC Code(s): 69139-106-01
  • Packager: YIWU HAODING MEDICAL CO.,LTD
  • 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 March 3, 2023

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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 condition persists or gets worse.

    Do not use longer than 1 week unless directed by a physician. In case of deep or puncture wounds, animal bites, or serious burn, consult a physician.

    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

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE ANTIBACTERIAL BANDAGES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69139-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69139-106-0130 in 1 BOX03/04/2023
    10.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2023
    Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384)
    Establishment
    NameAddressID/FEIBusiness Operations
    YIWU HAODING MEDICAL CO.,LTD421362384manufacture(69139-106)
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