Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

H.J. Harkins Company, Inc.
Nycomed US 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
• Warnings
• For external use only
• Keep out of reach of children.
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

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

Uses

• minor cuts
• scopes
• bums

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 bums

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 52959-014

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

Repacked by:

H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA