Triple Antibiotic Ointment

bacitracin zinc, neomycin sulfate, and polymyxin b sulfate

Dosage Form: ointment
Triple Antibiotic

Ointment

Drug Facts

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

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)

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

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (Bacitracin zinc) Bacitracin zinc 400 [iU]  in 1 g Neomycin sulfate (Neomycin) Neomycin sulfate 3.5 mg  in 1 g Polymyxin B sulfate (Polymyxin B) Polymyxin B sulfate 5000 [iU]  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52426-020-06 1 TUBE In 1 CARTON contains a TUBE 1 28.4 g In 1 TUBE This package is contained within the CARTON (52426-020-06) 2 52426-020-05 1 TUBE In 1 CARTON contains a TUBE 2 14.2 g In 1 TUBE This package is contained within the CARTON (52426-020-05)

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	Operations
SGS Life Science Services		093840643	ANALYSIS

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

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

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

Revised: 09/2010Phoenix Global Supply Group, Inc

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