DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 Item Code (Source) NDC:0168-0021
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum (UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0168-0021-35 1 in 1 CARTON
1 14.17 g in 1 TUBE
2 NDC:0168-0021-31 1 in 1 CARTON
2 28.35 g in 1 TUBE
3 NDC:0168-0021-09 1 in 1 CARTON
3 0.9 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/06/2010
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 2/2013
Document Id: 443a7f87-7fdc-4c44-aad9-f7d8441e7f2a
Set id: e7e3220c-6bc4-492e-838a-d0a0cb77a8a5
Version: 2
Effective Time: 20130212
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.