BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., Nycomed US Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

Antibiotic

Uses first aid to help prevent infection in minor cuts scrapes burns

Warnings For External use only

Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients

Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if the condition persists or gets worse if a rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of A finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Other information store at room temperature

Inactive ingredient white petrolatum

E. FOUGERA and CO.
a division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

Repacked by:
H.J. Harkins Company Inc.
Nipomo, CA 93444

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-113(NDC:0168-0011)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES)	Bacitracin Zinc	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: 52959-113-03	28.34 g in 1 TUBE
2	NDC: 52959-113-15	14.17 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/08/2010

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Business Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Nycomed US Inc.		043838424	ANALYSIS, MANUFACTURE