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 TRIFECTA PHARMACEUTICALS USA LLC, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each gram contains)

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings

For external use only.

Ask Doctor Before Use

Ask Doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Do Not Use

• In the eyes
• Over large areas of the body
• If you are allergic to any of the ingredients

Stop Use and ask a doctor

Stop Use and ask a doctor if

• Condition persists or gets worse
• You need to use longer than 1 week
• A rash or other allergic reaction develops

Directions

● clean the affected area and dry thoroughly.

● 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.

INACTIVE INGREDIENT

Inactive ingredient light Mineral Oil, White Petrolatum

Other information

● store at 20° to 25°C ( 68° to 77°F)

QUESTIONS

Questions? Call 1-760-642-2638

Manufactured For

Manufactured for

Urgent First Aid®

2603 Industry Street

Oceanside, CA 92054

www.urgentfirstaid.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-125
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-125-05	25 in 1 BOX	07/23/2023
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	07/18/2023

Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)