BACITRACIN ZINC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATUS PHARMACEUTICALS INC]

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BACITRACIN ZINC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATUS PHARMACEUTICALS INC]
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NDC 58980-012-01
Set ID f64b3564-ea3c-4316-8f00-f92c08dcad35
Category HUMAN OTC DRUG LABEL
Packager STRATUS PHARMACEUTICALS INC
Generic Name
Product Class
Product Number
Application Number PART333B
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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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