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

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRIPLE ANTIBIOTIC- neomycin and polymyxin b sulfates and bacitracin zinc 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 ® 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 CONTAINER

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 – 1/2 Oz CARTON

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 – 1/32 Oz CONTAINER

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®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON - 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0168-0012-351 in 1 CARTON01/06/201005/31/2019
114.17 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 0168-0012-311 in 1 CARTON01/06/201005/31/2019
228.35 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 0168-0012-09144 in 1 CARTON01/06/201005/31/2019
30.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/06/201005/31/2019
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 9/2019
Document Id: 5e2c2bd8-9f47-48f3-ae65-474d70f12f4f
Set id: b60b7ea1-7fda-4417-ac43-eb5129136b95
Version: 3
Effective Time: 20190910
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.