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 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• burn

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

Fougera®

NDC: 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON

NDC: 0168-0021-35

Fougera ®

Double
Antibiotic Ointment
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

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

NDC: 0168-0021-09

Fougera®

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

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B
Sulfate Ointment USP)
Uses: First aid to help prevent infection in
minor cuts scrapes burns

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

NDC: 0168-0021-09

Fougera ®

Double
Antibiotic Ointment
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

This product available in tubes at pharmacy.

1 GROSS
NET WT 0.9 g (1/32 Oz) FOILPACS®

INGREDIENTS AND APPEARANCE

DOUBLE ANTIBIOTIC 
bacitracin zinc and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0021
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: 0168-0021-35	1 in 1 CARTON
1		14.17 g in 1 TUBE
2	NDC: 0168-0021-31	1 in 1 CARTON
2		28.35 g in 1 TUBE
3	NDC: 0168-0021-09	1 in 1 CARTON
3		0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/06/2010

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)