Triple Antibiotic Ointment + Pain Relief

SPL v7

SPL

SPL Set ID 54c1d306-dc3b-2885-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2025-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Pramoxine (10 mg) Polymyxin B (10000 [USP'U])

Inactive Ingredients

White Petrolatum Mineral Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-07-20

Description

Bacitracin Zinc 500 Units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units

Uses

First Aid to help prevent infection in minor:

Cuts
Scrapes
Burns

Section 51945-4

Warnings

For external use only. Do not use:

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

Packaging

Directions

Clean the affected area
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

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Bacitracin Zinc 500 Units

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

Inactive Ingredient:

mineral oil, white Petrolatum

Ask A Doctor Before Use

Ask Doctor before use if you have:

Deep or puncture wouns
Animal bites
Serious burns

Keep Out of Reach of Children

If Swallowed, get medical help or contact a Poison Control Center right away

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

Structured Label Content

Uses

First Aid to help prevent infection in minor:

Cuts
Scrapes
Burns

Section 51945-4 (51945-4)

Purpose

First Aid Antibiotic

Warnings

For external use only. Do not use:

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

Packaging

Directions

Clean the affected area
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

Questions?

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Bacitracin Zinc 500 Units

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

Inactive Ingredient:

mineral oil, white Petrolatum

Ask A Doctor Before Use (Ask a Doctor before Use)

Ask Doctor before use if you have:

Deep or puncture wouns
Animal bites
Serious burns

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

Stop Use and Ask A Doctor If: (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

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "100", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "100", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First Aid to help prevent infection in minor: Cuts Scrapes Burns", "Purpose": "First Aid Antibiotic", "Warnings": "For external use only. Do not use: In eyes Over large areas of the body If you are allergic to any of the ingredients", "Directions": "Clean the affected area 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", "Questions?": "Call 1-888-296-9067", "Distributed By:": "Trifecta Pharmaceuticals USA ® 101 NE Third Avenue, Suite 1500 Fort Lauderdale, FL. 33301 USA www.trifecta-pharma.com", "Active Ingredient": "Bacitracin Zinc 500 Units", "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", "Inactive Ingredient:": "mineral oil, white Petrolatum", "Ask a Doctor before Use": "Ask Doctor before use if you have: Deep or puncture wouns Animal bites Serious burns", "Keep out of Reach of Children": "If Swallowed, get medical help or contact a Poison Control Center right away", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:43.772235 · Updated: 2026-03-14T23:13:10.446567