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 Provision Medical, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each gram)

Bacitracin zinc (400 units bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only

Do not use

• in eyes
• over large areas of the body or on puncture wounds, animal bites or serious burns
• for more than 1 week unless directed by a doctor
• if you are allergic to any of the ingredients

Stop use and ask a doctor if

• a rash or allergic reaction develops
• condition worsens or persists

Keep out of reach of children

If ingested, contact a Poison Control Center right away.

Directions

• clean affected area
• apply a small amount 1 to 3 times daily
• may cover with a sterile bandage

Inactive ingredients

petrolatum

Principal Display Panel - 0.5g Packet Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

ointment

Helps Prevent Infection in Cuts and Scrapes

TRIPLE ANTIBIOTIC

0.5g

The Provision First Aid LineTM

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-5005
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: 69103-5005-1	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	08/29/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5005)