Label: ANTIBIOTIC- bacitracin zinc ointment

  • 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 September 22, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)

    Bacitracin Zinc 400 units
    Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin)
    Polymyxin B Sulfate 5,000 units

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  • PURPOSE

    Purpose
    First Aid Antibiotic

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  • INDICATIONS & USAGE


    Uses
    First aid antibiotic to help prevent infection in: minor cuts, burns, scrapes

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  • WARNINGS


    Warnings

    For external use only.

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
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  • STOP USE

    Stop use and ask a doctor

    • before use in case of deep puncture wounds, animal bites or serious burns
    • if the condition persists or gets worse
    • if a rash or other allergic reaction develops


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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area
    • Apply a small amount of the 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


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  • OTHER SAFETY INFORMATION

    Other Information

    • Store at controlled room temperature 59° - 86°F (15° - 30°C)
    • Tamper Evident. Do not use if packet is torn, cut or opened
    • Avoid excessive heat and humidity


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  • INACTIVE INGREDIENT

    Inactive Ingredients

    White Petrolatum, Mineral Oil

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  • QUESTIONS

    Questions?

    Call 1-800-777-4908

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  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1183-1


    McKesson
    Triple Antibiotic Ointment
    WITH BACITRACIN, NEOMYCIN, & POLYMYXIN B
    First aid antibiotic to help prevent infection.

    box
    Distributed by
    McKesson Medical-Surgical Inc.
    Richmond, VA 23233
    Made in USA
    MFR # 118-42213

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  • PRINCIPAL DISPLAY PANEL

    Packet


    NDC 68599-1183-1


    McKesson
    Triple Antibiotic Ointment
    WITH BACITRACIN, NEOMYCIN, & POLYMYXIN B
    First aid antibiotic to help prevent infection.


    Net WT
    0.9g
    (0.03 oz)


    See Box for full Drug Facts Information.
    Not for individual sale.

    Distributed by
    McKesson Medical-Surgical Inc.
    Richmond, VA 23233
    Made in USA
    MFR # 118-42213

    each

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  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-1183
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-1183-1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 09/22/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 09/22/2017
    Labeler - McKesson (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal 085752004 manufacture(68599-1183)
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