BACITRACIN ZINC- bacitracin zinc and polymyxin b sulfate 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

Active ingredient (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Polymyxin B 10,000 units	First aid 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

Allergy alert

• do not use if allergic to any of the ingredients

When using this product

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

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

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

Stop use and ask a doctor if

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

Directions

• Clean the affected area
• Apply a small amount of this product on the area 1 to 3 times
• May be covered with a sterile bandage

Other information

• Store at room temperature
• Before using any medication, read all label directions.

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 - 0.9 g Packet Box

NDC: 58980-012-01

STRATUSCARE
Double Antibiotic
Ointment

(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

Distributed by:
STRATUS
PHARMACEUTICALS INC

1 GROSS

Net Wt. 0.9g (1/32 oz) PACKETTES

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-012
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [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: 58980-012-01	144 in 1 BOX	09/15/2017
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	09/15/2017

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-012) , LABEL(58980-012) , PACK(58980-012)