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 ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Purpose

First aid antibiotic

Uses

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

Warnings

For external use only

Do not use

• internally
• 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 ingredient

petrolatum

Principal Display Panel – 0.5g Pouch Label

Triple Antibiotic
Ointment

The Provision
First Aid
Line™

0.5 g
(1/57 oz.)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-5603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	5000 [iU]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-5603-1	0.5 g in 1 POUCH; Type 0: Not a Combination Product	07/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	07/25/2022

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(69103-5603)