BACITRACIN ZINC - bacitracin zinc ointment 
E. FOUGERA & CO., A division of Nycomed US Inc.

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Bacitracin Zinc Ointment USP

Drug Facts

Active ingredients (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 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

E. FOUGERA & CO., A division of Nycomed US Inc., Melville, New York 11747

L21116G R3/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER

Fougera®

NDC 0168-0011-04

NET WT 113.4 g (4 Oz)

FOR HOSPITAL USE ONLY

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

Antibiotic

Uses first aid to help prevent infection in minor cuts scrapes burns

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CARTON

NDC 0168-0011-04

Fougera ®

FOR HOSPITAL USE ONLY

Bacitracin Zinc

Ointment USP

First Aid Antibiotic

NET WT 113.4 g (4 Oz)

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

NDC 0168-0111-09

Fougera®

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

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 0168-0111-09

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 Type HUMAN OTC DRUG NDC Product Code (Source) 0168-0011 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (Bacitracin Zinc) Bacitracin Zinc 500 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0168-0011-35 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (0168-0011-35) 2 0168-0011-31 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (0168-0011-31) 3 0168-0011-04 1 TUBE In 1 CARTON contains a TUBE 3 114 g In 1 TUBE This package is contained within the CARTON (0168-0011-04) 4 0168-0011-16 454 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/08/2010

BACITRACIN ZINC  bacitracin zinc   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0168-0111 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (Bacitracin Zinc) Bacitracin Zinc 500 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0168-0111-09 144 PACKET In 1 CARTON contains a PACKET 1 1 g In 1 PACKET This package is contained within the CARTON (0168-0111-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/08/2010

Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS, MANUFACTURE

Revised: 01/2010E. FOUGERA & CO., A division of Nycomed US Inc.