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

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PHOENIX GLOBAL SUPPLY GROUP, INC]
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NDC	52426-120-05, 52426-120-06
Set ID	2c8b5a71-51cf-4274-aacc-411dfd1f05e5
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 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCI 10 mg	External analgesic

Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort 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
- adults and children 2 years of age and older:
  - 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
- children under 2 years of age: consult a doctor
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 + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Ointment

Maximum Strength

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52426-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES)	Bacitracin Zinc	500 [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	10000 [iU] in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg in 1 g

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

#	Item Code	Package Description
Packaging
1	NDC:52426-120-05	1 in 1 CARTON
1		14.2 g in 1 TUBE
2	NDC:52426-120-06	1 in 1 CARTON
2		28.4 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
Syn-Tech Chem. & Pharm. Co., Ltd.		656002532	API MANUFACTURE

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

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Medic

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

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