Label: TRIPLE ANTIBIOTIC OINTMENT - bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

  • NDC Code(s): 51141-0070-1, 51141-0070-3, 51141-0070-5
  • Packager: NeoPharm Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

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  • Active ingredient

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymyxin B Sulfate 5,000 units

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  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

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  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
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  • Warnings

    For external use only
    Do not use if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites

    When using this product

    • do not use in the eyes
    • do not apply over large areas of the body

    Stop use and ask a doctor if

    • you need to use more than 1 week
    • condition persists or gets worse
    • symptoms persist for more than 1 week or clear up and occur again within a few days.
    • 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.

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  • Directions

    • adults and children 2 years of age or older:
      • clean the affected area
      • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
      • may be covered with a sterile bandage
    • children under 2 years of age:  ask a doctor
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  • Other information

    • store at 59° to 77°F

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  • Inactive ingredients

    Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

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  • Package label panel

    Triple Antibiotic Ointmentimage of a carton

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  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC OINTMENT 
    bacitracin zinc, neomycin sulfate, polymyxin b ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51141-0070
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL  
    GLYCERIN  
    LIGHT MINERAL OIL  
    STEARETH-2  
    SQUALANE  
    STEARIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51141-0070-1 1 in 1 BOX
    1 28 g in 1 TUBE
    2 NDC:51141-0070-5 1 in 1 BOX
    2 14 g in 1 TUBE
    3 NDC:51141-0070-3 1 in 1 BOX
    3 9.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 09/01/2010
    Labeler - NeoPharm Co., Ltd (631101883)
    Registrant - NeoPharm Co., Ltd (631101883)
    Establishment
    Name Address ID/FEI Business Operations
    NeoPharm Co., Ltd 631101883 manufacture
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