BACITRACIN ZINC ointment

BACITRACIN ZINC by

Drug Labeling and Warnings

BACITRACIN ZINC by is a Otc medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gram)

Bacitracin Zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in

• minor cuts
• scrapes
• burns

Warnings

For external use only

Allergy alert

• do not use if allergic to any of the ingredients

Do not use

• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use longer then one week unless directed by doctor

Stop use and ask a doctor if

• condition persists or gets worse
• a rash or other allergic reaction develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean 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
• May be covered with a sterile bandage

Other information

• Store at room temperature 59°F - 77°F (15°C - 25°C)
• Before using any medication, read all label directions. Keep carton, it contains important information.
• Do not use if seal is punctured or is not visible
• See crimp of tube and outside of carton for Lot Number and Expiration Date.
• To open, reverse cap and puncture.

Inactive Ingredient

White petrolatum

Questions or comments?

Call toll-free 1-800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by: Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box

STRATUSCARE
NDC: 58980-011-10

Bacitracin Zinc Ointment USP

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 g)

Distributed by:
STRATUS
PHARMACEUTICALS INC

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-011
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)

Product Characteristics
Color	WHITE (OFF WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-011-10	1 in 1 BOX	09/15/2017
1		28.35 g in 1 TUBE; 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	09/15/2017

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-011) , LABEL(58980-011) , PACK(58980-011)