Triple Antibiotic (Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate) Ointment [Medsource Pharmaceuticals] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [MEDSOURCE PHARMACEUTICALS]
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NDC	45865-640-01
Set ID	72061450-572c-acb4-e053-2a95a90a0a99
Category	HUMAN OTC DRUG LABEL
Packager	Medsource Pharmaceuticals
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Drug Facts
Active ingredients (in each gram)

Bacitracin zinc, USP 400 units
Neomycin 3.5 mg
Polymyxin B sulfate, USP 5,000 units
Purpose

First aid antibiotic
Uses
First aid to help 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 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 controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
- Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive ingredient

white petrolatum
Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.
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	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45865-640-01	1 in 1 CARTON	01/01/2018
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	05/01/1997

Labeler - Medsource Pharmaceuticals (833685915)

Name	Address	ID/FEI	Business Operations
Establishment
Medsource Pharmaceuticals		833685915	repack(45865-640)

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Medic