Label: SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hydrochloride ointment

  • NDC Code(s): 11527-161-55
  • 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

    Neomycin 3.5 mg

    Polymyxin B 10,000 units

    Pramoxine hydrochloride 10mg

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Pain reliever

  • Uses

    helps prevent infection in and temporarily relieves pain due to:

    • 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

    Dr. Sheffield's NDC 11527-161-55

    Triple Antibiotic Plus Pain Relief 
    Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate •  Pramoxine HCL             
    First Aid Antibiotic  Plus Pain Relieving Ointment

    NET WT. 1 OZ (28 g)

    Principal Display Panel – Carton Label

    Principal Display Panel – Carton Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    Dr. Sheffield's NDC 11527-161-55

    Triple Antibiotic Plus Pain Relief

    Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate • Pramoxine HCL    
    First Aid Antibiotic/Pain Relieving Ointment

    NET WT. 1 OZ (28 g)
    First Aid Treatment for Minor Cuts, Scrapes and Burns

    Principal Display Panel – Tube Label

  • INGREDIENTS AND APPEARANCE
    SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-161
    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
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-161-551 in 1 CARTON01/23/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/23/2011
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-161)
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