Triple Antibiotic Ointment

Triple Antibiotic Ointment
SPL v1
SPL
SPL Set ID 3244d91e-6c6b-a351-e063-6294a90aa02d
Route
TOPICAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
White Petrolatum Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-08

Description

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

Purpose

First aid antibiotic


Medication Information

Warnings and Precautions

Warnings    For external use only.

Do not use ● in the eyes                             ● over large areas of the body

                   ● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds                     ● animal bites                        ● serious burns.

Stop use and ask a doctor ifcondition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops 

Indications and Usage

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

Purpose

First aid antibiotic

Description

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

Section 42229-5

Distributed by:



Trifecta Pharmaceuticals USA®



Ft. Lauderdale, FL 33301, USA



1-888-296-9067

Section 50565-1

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

Section 51727-6

Inactive ingredient Mineral Oil, White Petrolatum

Section 53413-1

Questions?   Call 1-888-296-9067

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.

Package Label

Other Information



● store at 20° to 25°C ( 68° to 77°F)

Active Ingredients (each Gram Contains)

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg 

Polymyxin B sulfate 5,000 units


Structured Label Content

Indications and Usage (34067-9)

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

Warnings and Precautions (34071-1)

Warnings    For external use only.

Do not use ● in the eyes                             ● over large areas of the body

                   ● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds                     ● animal bites                        ● serious burns.

Stop use and ask a doctor ifcondition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops 

Section 42229-5 (42229-5)

Distributed by:



Trifecta Pharmaceuticals USA®



Ft. Lauderdale, FL 33301, USA



1-888-296-9067

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredient Mineral Oil, White Petrolatum

Section 53413-1 (53413-1)

Questions?   Call 1-888-296-9067

Purpose

First aid antibiotic

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.

Package Label

Other Information (Other information)



● store at 20° to 25°C ( 68° to 77°F)

Active Ingredients (each Gram Contains) (Active ingredients (each gram contains))

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg 

Polymyxin B sulfate 5,000 units


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)