REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]

  • Home
  • REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]

REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]
PDF | XML
NDC 50814-011-01, 50814-013-01, 50814-016-01
Set ID b479c3e9-cccc-4734-87cd-4d7dfc00ca1d
Category HUMAN OTC DRUG LABEL
Packager GFA Production (Xiamen) Co., Ltd.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs