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Double Antibiotic

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

Fougera Double Antibiotic Ointment(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

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 serious 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 store at room temperature

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 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

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

NDC 0168-0021-35

Fougera ®

Double
Antibiotic Ointment
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

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

NDC 0168-0021-09

Fougera®

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

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B
Sulfate Ointment USP)
Uses: First aid to help prevent infection in
• minor cuts • scrapes • burns

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

NDC 0168-0021-09

Fougera ®

Double
Antibiotic Ointment
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

This product available in tubes at pharmacy.

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

Double Antibiotic

Bacitracin Zinc and Polymyxin B Sulfate OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0168-0021
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BACITRACIN ZINC BACITRACIN 500 [USP'U]
Polymyxin B Sulfate POLYMYXIN B 10000 [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:0168-0021-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2010-01-06


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