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

Sheffield Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Sheffield Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. (28g)

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. (28g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-161-55	1 in 1 CARTON	01/23/2011
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/23/2011

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-161)