DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

Double Antibiotic by

Drug Labeling and Warnings

Double Antibiotic by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Polymyxin B sulfate 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
• if you are allergic to any of the ingredients
• longer than 1 week

Ask a doctor before use

• on deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

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

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area and dry thoroughly
• 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

• To open: unscrew cap, pull tab to remove foil seal.
• store between 20° and 25°C (68° and 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC: 51672-2044-2

Compare to the
active ingredients in
Polysporin®*

Original Strength

Double Antibiotic
Ointment

Bacitracin Zinc Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

DOUBLE ANTIBIOTIC 
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2044
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2044-2	1 in 1 CARTON	09/06/2018
1		28.4 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	12/05/1990

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2044)