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

  • NDC Code(s): 58980-012-01, 58980-012-05
  • Packager: STRATUS PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL

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 February 10, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each gram)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Polymyxin B 10,000 unitsFirst aid antibiotic
  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • 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
  • 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
  • Other information

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

    White petrolatum

  • Questions or comments?

    Call toll-free 1-800-442-7882

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITE (OFF WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-012-01144 in 1 BOX09/15/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:58980-012-051 in 1 BOX02/08/2021
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B09/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-012) , LABEL(58980-012) , PACK(58980-012)
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