Triple Antibiotic (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) Ointment [Prostat First Aid] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROSTAT FIRST AID]
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NDC	58228-5600-0, 58228-5600-1, 58228-5600-2
Set ID	f588bd1b-6087-453a-b268-e1ec4241c37e
Category	HUMAN OTC DRUG LABEL
Packager	ProStat First Aid
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients (each gram contains)

Bacitracin zinc 400 units

Neomycin sulfate 5 mg
(equivalent to 3.5 mg of neomycin base)

Polymyxin B sulfate 5000 units
Purpose

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 or apply over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
Stop use and ask a doctor if
- the condition worsens
- 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 15°-25°C (59°-77°F)
- tamper evident sealed packets
- do not use packet if opened or torn
Inactive ingredients

petrolatum
Questions?

888.900.2920

prostatfa.com
PRINCIPAL DISPLAY PANEL – ProStat 25 count box

PROSTAT
FIRST AID

Part No. #2009

Triple Antibiotic
Bacitracin, Neomycin, Polymyxin

Ungüento Triple Antibiotico
Bacitracina, neomicina, polimixina

25 pcs Unit Dose • 0.5g - (1/55 oz) each
PRINCIPAL DISPLAY PANEL – Front Line 25 count box

FRONT LINE

Triple Antibiotic
Bacitracin, Neomycin, Polymyxin

Ungüento Triple Antibiotico
Bacitracina, neomicina, polimixina

25 pcs Unit Dose • 0.5g - (1/55 oz) each
PRINCIPAL DISPLAY PANEL – packet

PROSTAT
FIRST AID

Triple Antibiotic

0.5 g (1/57oz)

Distributed by:
ProStat First Aid LLC,
Valencia, CA 91355

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58228-5600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I)	bacitracin	400 [USP'U] 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 [USP'U] in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58228-5600-1	25 in 1 BOX	09/20/2013
1	NDC:58228-5600-0	0.5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:58228-5600-2	25 in 1 BOX	09/20/2013
2	NDC:58228-5600-0	0.5 g in 1 PACKET; 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	09/20/2013

Labeler - ProStat First Aid (061263699)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(58228-5600)

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Medic

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROSTAT FIRST AID]

Do not use:

Stop use and ask a doctor if

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