SHEFFIELD BACITRACIN ZINC- bacitracin zinc ointment

Sheffield Bacitracin Zinc by

Drug Labeling and Warnings

Sheffield Bacitracin Zinc 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

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

Dr. Sheffield's NDC: 11527-163-51

Bacitracin Zinc Ointment USP Bacitracin Zinc

First Aid Antibiotic Ointment

NET WT. 0.5 oz. (14g)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

Dr. Sheffield's NDC: 11527-163-51

Bacitracin Zinc Ointment Bacitracin Zinc

First Aid Antibiotic Ointment

NET WT. 0.5 oz. (14g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

INGREDIENTS AND APPEARANCE

SHEFFIELD BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-163
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-163-51	1 in 1 CARTON	09/25/2012
1		14 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	09/25/2012

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-163)