AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

American Safety and First Aid Triple Antibiotic by

Drug Labeling and Warnings

American Safety and First Aid Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each gram)

Bacitracin zinc 400 units

Neoycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B sulfate 5,000 units

Purpose

First Aid antibiotic

First Aid antibiotic

First Aid antibiotic

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• burns

Warning

For external use only.

DO NOT USE

Do not use

• in eyes
• 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

Stop use and ask a doctor if

• the condition persists or gets worse
• a rash or other allergic reaction develops

Keep out of reach of children.

If swallowed contact a Poison Control Center right away.

Directions

• clean affected area
• apply small amount not more than 3 times daily
• may be covered with a sterile bandage

Inactive Ingredient

Mineral Oil, Petrolatum, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-016
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	0.0035 g  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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-016-03	144 in 1 BOX	10/17/2022
1	NDC: 71927-016-01	0.5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	10/17/2022

Labeler - Orazen Inc (080916640)