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

Medically reviewed on October 23, 2017

Dosage form: ointment
Ingredients: Bacitracin Zinc 400[USP'U] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, Polymyxin B Sulfate 5000[USP'U] in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0012

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

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

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

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 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
  • 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 0168-0012-35

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

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

NDC 0168-0012-35

Fougera ®

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

The economical way to help treat
minor cuts, scrapes, and burns.

First Aid Antibiotic

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

NDC 0168-0012-09

Fougera®

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


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

Uses: First aid to help prevent infection in
• minor cuts • scrapes • burns

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

NDC 0168-0012-09

Fougera ®

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

First Aid Antibiotic

This product available in tubes at pharmacy.

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

TRIPLE ANTIBIOTIC 
neomycin and polymyxin b sulfates and bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (BACITRACIN) Bacitracin Zinc400 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:0168-0012-351 TUBE in 1 CARTON
114.17 g in 1 TUBE
2NDC:0168-0012-311 TUBE in 1 CARTON
228.35 g in 1 TUBE
3NDC:0168-0012-09144 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)
Establishment
NameAddressID/FEIOperations
Fougera Pharmaceuticals Inc.043838424ANALYSIS(0168-0012), MANUFACTURE(0168-0012)

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

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Further information

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

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