Double Antibiotic Ointment

SPL v7

SPL

SPL Set ID 4eb5202e-8e5b-6d31-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2026-03-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polymyxin B (10000 [USP'U]) Bacitracin (500 [USP'U])

Inactive Ingredients

Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-05-04

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

Label

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For External use only.

Do not use

If you are allergic to any of the ingredients
in the eyes
over large areas of the body

Ask a doctor before use if you have:

deep puncture wounds
animal bites
serious burns

Packaging

Questions?

Call 1-888-296-9067

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

Distributed By:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL, 33301, USA

1-888-296-9067

www.trifecta-pharma.com

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®

Active Ingredient

Bacitracin Zinc 500 Units

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

White Petrolatum

Mineral Oil

Stop Use and Ask Doctor If:

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

Structured Label Content

Uses

First aid to help prevent infection in minor

cuts
scrapes
burns

Label (LABEL)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

First Aid Antibiotic

Warnings

For External use only.

Do not use

If you are allergic to any of the ingredients
in the eyes
over large areas of the body

Ask a doctor before use if you have:

deep puncture wounds
animal bites
serious burns

Packaging

Questions?

Call 1-888-296-9067

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

Distributed By:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL, 33301, USA

1-888-296-9067

www.trifecta-pharma.com

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®

Active Ingredient

Bacitracin Zinc 500 Units

Other Information

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

White Petrolatum

Mineral Oil

Stop Use and Ask Doctor If: (Stop use and ask doctor if:)

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

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection in minor cuts scrapes burns", "50565-1": "If swallowed, get medical help or contact a Poison Control Center immediately.", "Purpose": "First Aid Antibiotic", "Warnings": "For External use only. Do not use If you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have: deep puncture wounds animal bites serious burns", "Questions?": "Call 1-888-296-9067", "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", "Distributed By:": "Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL, 33301, USA 1-888-296-9067 www.trifecta-pharma.com *This product is not manufactured or distributed by Johnson & Johnson Consumer Products company, owner of the registered trademark Polysporin®", "Active Ingredient": "Bacitracin Zinc 500 Units", "Other Information": "Store between 20° to 25°C (68° to 77°F)", "Inactive Ingredients": "White Petrolatum Mineral Oil", "Stop use and ask doctor if:": "You need to use longer than 1 week Condition persists or gets worse rash or other allergic reaction develops"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.378620 · Updated: 2026-03-14T23:14:04.878170