TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

TRIPLE ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

PURPOSE

First aid antibiotic

USES

Helps 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 than 1 week unless directed by a doctor

STOP USE AND ASK A DOCTOR IF

• condition persists or gets worse
• 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 affected area
• apply a small 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 controlled room temperature 59º - 86ºF (15º - 30ºC).
• Protect from freezing.

INACTIVE INGREDIENT

White petrolatum

HOW SUPPLIED

Triple Antibiotic Ointment comes in 28gr tubes

NDC - 68788-9811-2

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Relabeled By Preferred Pharmaceuticals, Inc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9811(NDC:0472-0179)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B SULFATE	5000 [iU]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9811-2	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/25/2012

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc		791119022	RELABEL(68788-9811)