Triple Antibiotic

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

Fougera Triple Antibiotic Ointment(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
• Active ingredients (in each gram)
• Purpose
  • Triple Antibiotic Uses
• Warnings
• For external use only
• Keep out of reach of children.
  • Directions
  • Triple Antibiotic Other information
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each gram)

•   Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
•   Polymyxin B Sulfate (equal to 5,000 polymyxin B units)
•   Bacitracin Zinc (equal to 400 bacitracin units)

Purpose

Antibiotic
Antibiotic
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 in case of deep or puncture wounds, animal bites or serous burns

When using this product do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

• the condition persists or gets worse
• if 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

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
• store at room temperature
• see crimp of tube for Lot No. and Exp. date

Inactive ingredient white petrolatum

Questions or comments? call toll free 1-800-645-9833

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

Fougera^®

NDC 0168-0012-35

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON

NDC 0168-0012-35

Fougera ^®

^{Triple
Antibiotic Ointment
(Neomycin and Polymyxin B
Sulfates and Bacitracin Zinc
Ointment USP)}

The economical way to help treat
minor cuts, scrapes, and burns.

First Aid Antibiotic

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

NDC 0168-0012-09

Fougera^®

First Aid Antibiotic NET WT 0.9 g (1/32 Oz)

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates
and Bacitracin Zinc Ointment USP)

Uses: First aid to help prevent infection in
• minor cuts • scrapes • burns

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

NDC 0168-0012-09

Fougera ^®

Triple
Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates
and Bacitracin Zinc Ointment USP)

First Aid Antibiotic

This product available in tubes at pharmacy.

1 GROSS
NET WT 0.9 g (1/32 Oz) FOILPACS^®

Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT Product Information Product Type Human otc drug label Item Code (Source) NDC:0168-0012 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC BACITRACIN 400 [USP'U] Neomycin Sulfate NEOMYCIN 3.5 mg Polymyxin B Sulfate POLYMYXIN B 5000 [USP'U] Inactive Ingredients Ingredient Name Strength petrolatum Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14.17 in 1 TUBE 2 28.35 in 1 TUBE 3 0.9 in 1 PACKET 4 NDC:0168-0012-09 144 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date partB part333B 2010-01-06