POLY BACITRACIN- bacitracin zinc and polymyxin b sulfate ointment

Poly Bacitracin by

Drug Labeling and Warnings

Poly Bacitracin by is a Otc medication manufactured, distributed, or labeled by Phoenix Global Supply Group, Inc, Axellia Pharmaceuticals AS, Axellia Pharmaceuticals ApS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid 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 if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• condition persists or gets worse
• you need to use longer than 1 week
• 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

• To open: unscrew cap, pull tab to remove foil seal.
• store at 20°-25°C (68°-77°F)
• See carton or tube crimp for lot number and expiration date.

Inactive ingredient

white petrolatum

Questions?

Call 1-877-745-6888

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Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Poly Bacitracin
Bacitracin Zinc Polymyxin B Sulfate

First Aid Antibiotic Ointment

NDC: 52426-420-06

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

POLY BACITRACIN 
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52426-420
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 [iU]  in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B sulfate	10000 [iU]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52426-420-05	1 in 1 CARTON
1		14.2 g in 1 TUBE
2	NDC: 52426-420-06	1 in 1 CARTON
2		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	09/23/2010

Labeler - Phoenix Global Supply Group, Inc (843189908)

Establishment
Name	Address	ID/FEI	Business Operations
Axellia Pharmaceuticals AS		561816174	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Axellia Pharmaceuticals ApS		305814345	MANUFACTURE