BACITRACIN ZINC AND POLYMYXIN B SULFATE ointment

Bacitracin Zinc and Polymyxin B Sulfate by

Drug Labeling and Warnings

Bacitracin Zinc and Polymyxin B Sulfate 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)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses first aid to help prevent infection in

• minor cuts
• scrapes
• burn

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 bums

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

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal store at room temperature
• see crimp of tube for Lot No. and Exp. date

Inactive ingredient white petrolatum

Questions or comments ? call toll free 1-800-645-9833

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

Fougera®

NDC: 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

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

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC AND POLYMYXIN B SULFATE 
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-054(NDC:0168-0021)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin Zinc	500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B Sulfate	1000 [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: 52959-054-03	14.17 g in 1 TUBE
2	NDC: 52959-054-07	28.34 g in 1 TUBE
3	NDC: 52959-054-44	144 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/06/2010

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

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