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Double Antibiotic

Preferred Pharmaceuticals, Inc.
Preferred 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

28gr tube - 68788-9488-2

Fougera ®

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

First Aid Antibiotic

Double Antibiotic

Bacitracin Zinc and Polymyxin B Sulfate OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9488(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 28.35 in 1 TUBE
2 NDC:68788-9488-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2014-05-20


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