Triple Antibiotic Ointment

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])

Inactive Ingredients

Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-03-18

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 if ● condition 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™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

www.trifecta-pharma.com

Section 50565-1

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

Center right away.

Section 51727-6

Inactive ingredient Light Mineral Oil, Petrolatum

Section 53413-1

Questions? Call 1-888-296-9067

Packaging

Drug Facts

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

Other Information

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C (68° to 77°F)

● see carton or tube crimp for lot number and expiration date

Active Ingredient (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 if ● condition 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™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

www.trifecta-pharma.com

Section 50565-1 (50565-1)

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

Center right away.

Section 51727-6 (51727-6)

Inactive ingredient Light Mineral Oil, Petrolatum

Section 53413-1 (53413-1)

Questions? Call 1-888-296-9067

Purpose

First aid antibiotic

Packaging

Drug Facts (DRUG FACTS)

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

Other Information (Other information)

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C (68° to 77°F)

● see carton or tube crimp for lot number and expiration date

Active Ingredient (each Gram Contains) (Active ingredient (each gram contains))

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Advanced Ingredient Data

[{"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses first aid to help prevent infection in minor: ● cuts ● scrapes ● burns", "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 if ● condition persists or gets worse ● you need to use longer than 1 week ● a rash or other allergic reaction develops", "42229-5": "Distributed by: Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA www.trifecta-pharma.com", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredient Light Mineral Oil, Petrolatum", "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", "Other information": "● To open: unscrew cap, pull tab to remove foil seal ● store at 20° to 25°C (68° to 77°F) ● see carton or tube crimp for lot number and expiration date", "Active ingredient (each gram contains)": "Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units"}