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Bacitracin Zinc by E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

Medically reviewed on Aug 15, 2018

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[USP'U] in 1g
Labeler: E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0011

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.

Bacitracin Zinc Ointment USP

Active Ingredient (in each gram):

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose:

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 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:

  • 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 Number and Exp. Date

Inactive Ingredients

white petrolatum

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER

NDC 0168-0011-04

Fougera®

NET WT 113.4 g (4 Oz)

FOR HOSPITAL USE ONLY

Bacitracin Zinc Ointment USP

First Aid Antibiotic

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton

Fougera ®

Bacitracin Zinc
Ointment USP

First Aid Antibiotic

NDC 0168-0011-04

FOR HOSPITAL USE ONLY

NET WT 113.4 g (4 Oz)

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

Fougera®

First Aid Antibiotic

Bacitracin Zinc
Ointment USP

Uses: First aid to help prevent infection

in . minor cuts . scrapes . burns

NET WT. 0.9 g (1/32 Oz)

NDC 0168-0111-09

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

NDC 0168-0111-09

Fougera ®

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 – 1 lb jar CONTAINER

Fougera®

NDC 0168-0011-16

NET WT 453.6 g (1 lb)

Bacitracin Zinc Ointment USP

First Aid Antibiotic FOR HOSPITAL USE ONLY

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:0168-0011-351 TUBE in 1 CARTON
114.17 g in 1 TUBE
2NDC:0168-0011-311 TUBE in 1 CARTON
228.35 g in 1 TUBE
3NDC:0168-0011-041 TUBE in 1 CARTON
3113.4 g in 1 TUBE
4NDC:0168-0011-16453.6 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/08/2010
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:0168-0111-09144 PACKET in 1 CARTON
10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/08/2010
Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)

 
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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