Label: REFILL 2- benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

  • NDC Code(s): 50814-011-01, 50814-013-01, 50814-016-01
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 6, 2019

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc (bacitracin 400 units)

    Neomycin sulfate (neomycin 3.5mg)

    Polymyxin B sulfate (polymyxin B 5,000 units)

    Purpose

    First aid antibiotic

  • Use

    • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • Warnings

    For external use only.

    Do not use

    • in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • deep or punture wounds • animal bites • serious burns.

    Stop use and ask a doctor if

    • the condition persists or gets worse • a rash or other allergic reaction develops.

    Keep out of reach of children.

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

  • Directions

    • Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Mineral oil, petrolatum, purified water

  • DRUG FACTS

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose

    First Aid Antiseptic

  • Use:

    For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

  • Warnings

    For external use only.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

    Do not use:

    In the eyes, or over large areas of the body.

  • Directions:

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

  • Inactive ingredient:

    Purified water.

  • Antibiotic Application (50814-013-01) Labeling:

    Antibiotic Application

  • Antiseptic Towelettes (50814-011-01) Labeling:

    Towelettes

  • Refill 2 (50814-016-01) Labeling:

    Refill 2

  • INGREDIENTS AND APPEARANCE
    REFILL 2 
    benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-016
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-016-011 in 1 KIT08/10/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 120 PATCH 18 g
    Part 210 PACKET 9 g
    Part 1 of 2
    ANTISEPTIC TOWELETTES 
    benzalkonium chloride cloth
    Product Information
    Item Code (Source)NDC:50814-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-011-012 in 1 BOX
    110 in 1 BOX
    10.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2016
    Part 2 of 2
    ANTIBIOTIC APPLICATION 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:50814-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-013-011 in 1 BOX
    110 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/10/2016
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-016, 50814-011, 50814-013)
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