BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram):

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose:

Antibiotic

INDICATIONS & USAGE

Uses:

first aid to help prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0011-35	1 in 1 CARTON
1		14.17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0168-0011-31	1 in 1 CARTON
2		28.35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0168-0011-04	1 in 1 CARTON
3		113.4 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0168-0011-16	453.6 g in 1 JAR; Type 0: Not a Combination Product

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	Item Code (Source)	NDC: 0168-0111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0111-09	144 in 1 CARTON
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

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 Fougera Pharmaceuticals Inc. (043838424)