Label: SHEFFIELD BACITRACIN ZINC- bacitracin zinc ointment

  • NDC Code(s): 11527-163-15, 11527-163-30, 11527-163-51
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (In each gram)

    Bacitracin 500

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy alert:

    • do not use if you are allergic to any of the ingredients

    Do not use

    • in or near the eyes
    • on large areas of the body

    Consult a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week

    Stop use and consult a doctor if

    • condition persists or gets worse
    • symptoms last for more than 7 days or clear up and come back within a few days
    • a rash or other allergic reaction develops

    Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
  • Other information

    • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
  • Inactive ingredient

    Petrolatum

  • Questions? 1-800-222-1087

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    Principal Display Panel – Carton Label

    Sheffield NDC 11527-163-15

    Bacitracin Zinc Ointment USP Bacitracin Zinc

    First Aid Antibiotic Ointment

    NET WT. 15g (0.52oz)

    Principal Display Panel – Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    Principal Display Panel – Tube Label

    Sheffield NDC 11527-163-15

    Bacitracin Zinc Ointment Bacitracin Zinc

    First Aid Antibiotic Ointment

    NET WT. 15g (0.52oz)
    First Aid Treatment for Minor Cuts, Scrapes and Burns

    Principal Display Panel – Tube Label

  • INGREDIENTS AND APPEARANCE
    SHEFFIELD BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-163-511 in 1 CARTON09/25/2012
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11527-163-151 in 1 CARTON12/22/2020
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11527-163-301 in 1 PACKAGE12/22/2020
    330 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00409/25/2012
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-163) , analysis(11527-163)
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