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Double Antibiotic by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[USP'U] in 1g, Polymyxin B Sulfate 10000[USP'U] in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0021

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin500 [USP'U]  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:0168-0021-351 TUBE (1 TUBE) in 1 CARTON
114.17 g in 1 TUBE
2NDC:0168-0021-311 TUBE (1 TUBE) in 1 CARTON
228.35 g in 1 TUBE
3NDC:0168-0021-091 PACKET (1 PACKET) in 1 CARTON
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/06/2010
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

← See all Double Antibiotic brands

Medically reviewed on Feb 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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