TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Phoenix Global Supply Group, Inc, SGS Life Science Services, Axellia Pharmaceuticals ApS, Pharmacia and UpJohn Company, Axellia Pharmaceuticals AS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 400 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 5,000 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
• condition persists for more than 7 days
• condition clears up and occurs again within a few days
• 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

• 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

Triple Antibiotic
Ointment
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate

First Aid Antibiotic Ointment

Original Strength

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52426-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES)	Bacitracin zinc	400 [iU]  in 1 g
Neomycin sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin sulfate	3.5 mg  in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B sulfate	5000 [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: 52426-020-06	1 in 1 CARTON
1		28.4 g in 1 TUBE
2	NDC: 52426-020-05	1 in 1 CARTON
2		14.2 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
SGS Life Science Services		093840643	ANALYSIS

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

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia and UpJohn Company		829076566	MANUFACTURE

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