MAJOR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [MAJOR PHARMACEUTICALS]

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  • MAJOR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [MAJOR PHARMACEUTICALS]

MAJOR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [MAJOR PHARMACEUTICALS]
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NDC 0904-6680-67
Set ID fa696eab-aa51-4f5f-ae34-6e41100c92a1
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (In each gram)

    Bacitracin 400

    Neomycin 3.5 mg

    Polymyxin B 5,000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy Alert do not use if you are allergic to any of the ingredients 

    Do not use

    • in or near the eyes
    • on large areas of the body

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week

    Stop use and consult a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
  • Other information

    • Store at a controlled room temperature 20°C to 25°C(68º-77ºF)
  • Inactive ingredient

    Petrolatum

  • Questions? 1-800-616-2417

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    Major NDC 0904-6680-67

    Triple Antibiotic Ointment

    144 Unit Dose Packets 

    Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate
    First Aid Antibiotic Ointment

    Prevents infaction in Minor 

    • Cuts 
    • Burns
    • Scraps 

    NET WT. 0.9 g (0.03 oz ) PACKETS

    Principal Display Panel – Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Packet Label

    Major NDC 0904-6680-67

    Triple Antibiotic OintmentBacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate
    First Aid Antibiotic Ointment

    First Aid Treatment for Minor Cuts, Scrapes and Burns

    NET WT 0.9g (0.03oz)

    Principal Display Panel – Packet Label

  • INGREDIENTS AND APPEARANCE
    MAJOR TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [USP'U]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6680-67144 in 1 CARTON10/04/2018
    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 finalpart333B10/04/2018
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Major Pharmaceuticals (191427277)
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