Label: ALLSEASON ANTIBACTERIAL BANDAGE- benzalkonium chloride dressing

  • 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 June 6, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.9g /m2

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For use in minor cuts, scrapes and burns.Proper care is important to avoid infections or future complications.

  • DOSAGE & ADMINISTRATION

    Directions:

    For optimal results, apply bandage to clean, dry skin. Change the dressing daily, when wet, ot more often if needed.

  • WARNINGS

    Warning:

    For external use only. In case of deep cut, puncture wounds, animal bites, or serious burns,consult a doctor if the condition persists or gets worse.

    Keep this and all drugs out of reach of children

    Do not Use:

    Do not use in the eyes or apply over large areas of the body

    Do not use longer than one week unless directed by a doctor

    Stop Use:

    If adhere to the skin, and if individual person has an allergy with it, stop use it.

  • ASK DOCTOR

    Consult a doctor if the condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • SPL UNCLASSIFIED SECTION

    Other Information

    Store at room temperature

    Avoid excessive heat (above 40C)

    Protect from freezing

    Latex free

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    HDPE, Cellulose

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALLSEASON ANTIBACTERIAL BANDAGE 
    benzalkonium chloride dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72306-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.28 mg  in 3.125 cm2
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA CELLULOSE (UNII: I355QGZ19A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72306-001-0130 in 1 PACKAGE06/05/2018
    13.125 cm2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/05/2018
    Labeler - Excellence Medical Supplies Co., Ltd. (527730762)
    Registrant - Excellence Medical Supplies Co., Ltd. (527730762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excellence Medical Supplies Co., Ltd.527730762manufacture(72306-001)