Triple Antibiotic (Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate) Ointment [Phoenix Global Supply Group, Inc] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PHOENIX GLOBAL SUPPLY GROUP, INC]
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NDC	52426-020-05, 52426-020-06
Set ID	1024da1e-98e7-46d5-b7a7-eb556686adcb
Category	HUMAN OTC DRUG LABEL
Packager	Phoenix Global Supply Group, Inc
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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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)

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333B	09/23/2010

Labeler - Phoenix Global Supply Group, Inc (843189908)

Name	Address	ID/FEI	Business Operations
Establishment
SGS Life Science Services		093840643	ANALYSIS

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

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

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

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Medic

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [PHOENIX GLOBAL SUPPLY GROUP, INC]

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