Label: BACITRACIN ZINC- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 58980-012-01
  • Packager: STRATUS PHARMACEUTICALS INC
  • 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 November 2, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each gram) Purpose
    Bacitracin zinc 500 units First aid antibiotic
    Polymyxin B 10,000 units 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

    • in the eyes
    • over large areas of the body

    Allergy alert

    • do not use if allergic to any of the ingredients

    When using this product

    • do not use longer then one week unless directed by doctor

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops
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  • Directions

    • Clean the affected area
    • Apply a small amount of this product on the area 1 to 3 times
    • May be covered with a sterile bandage
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  • Other information

    • Store at room temperature
    • Before using any medication, read all label directions.
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  • Inactive ingredient

    White petrolatum

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  • Questions or comments?

    Call toll-free 1-800-442-7882

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

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  • PRINCIPAL DISPLAY PANEL - 0.9 g Packet Box

    NDC 58980-012-01

    STRATUSCARE
    Double Antibiotic
    Ointment

    (Bacitracin Zinc and
    Polymyxin B Sulfate Ointment USP)

    First Aid Antibiotic

    Distributed by:
    STRATUS
    PHARMACEUTICALS INC

    1 GROSS

    Net Wt. 0.9g (1/32 oz) PACKETTES

    Principal Display Panel - 0.9 g Packet Box
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-012
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color WHITE (OFF WHITE) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-012-01 144 in 1 BOX 09/15/2017
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333B 09/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-012) , LABEL(58980-012) , PACK(58980-012)
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