Triple Antibiotic (Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate) Ointment [Preferred Pharmaceuticals, Inc] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]
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NDC	68788-9811-2
Set ID	149065ec-0c18-43e7-89de-6540bf48207b
Category	HUMAN OTC DRUG LABEL
Packager	Preferred Pharmaceuticals, Inc
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - Preferred Pharmaceuticals, Inc (791119022)

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

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