SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hydrochloride  ointment 
Sheffield Pharmaceuticals LLC

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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:

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

Other information

Inactive ingredient

Petrolatum

Questions? 1-800-222-1087

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 – 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

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)

Revised: 11/2023
Document Id: d91f9d30-8d50-4e41-8ba5-38989db9180b
Set id: 485a779c-017b-4064-a446-e5073c1bdb07
Version: 4
Effective Time: 20231120
 
Sheffield Pharmaceuticals LLC