TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [DELSAM PHARMA LLC]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [DELSAM PHARMA LLC]
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NDC 72570-107-30
Set ID d5968987-9a04-4f21-adda-a0260092b0eb
Category HUMAN OTC DRUG LABEL
Packager Delsam Pharma Llc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Drug Facts

  • Active ingredients

    Bacitracin zinc 400 units

    Neomycin sulfate 3.5 mg

    Polymyxin B sulfate 5,000 units

  • Purpose

    First aid antibiotic

  • Uses

    first aid to help prevent infection in minor: • cuts • scrapes • burns

  • Warnings

    For external use only

    Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body

    Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

    Stop use and ask a doctor if
    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    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

  • Inactive ingredients

    White Petroleum Jelly, Light Liquid paraffin, Cetomacrogol 1000, methylparaben, propylparaben.

  • Other information

    • store at 20° to 25°C (68° to 77°F)

  • Questions or comments?

    1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

  • SPL UNCLASSIFIED SECTION

    Bacitracin Zinc | Neomycin Sulfate | Polymyxin B Sulfate

    *Compare to the active ingredients in NEOSPORIN®

    This product is not manufactured or distributed by Johnson & Johnson Consumer Companies, Inc., owner of the registered trademark Neosporin®

    Distributed by:

    Delsam Pharma Llc

    Bronx, Newyork 10467

  • Packaging

    Tripanti1

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETETH-20 (UNII: I835H2IHHX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-107-301 in 1 CARTON09/25/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/25/2018
    Labeler - Delsam Pharma Llc (081369679)

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