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 ProStat First Aid, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	09/20/2013

Labeler - ProStat First Aid (061263699)

Registrant - Safetec of America, Inc. (874965262)

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