Bacitracin Zinc Ointment Usp

SPL v9

SPL

SPL Set ID 4a9fe0fa-5549-4e06-e054-00144ff8d46c

Route

TOPICAL

Published

Effective Date 2025-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

Mineral Oil Petrolatum Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-03-15

Description

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units per gram

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, longer than 1 week unless directed by a doctor.

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

Package Label

Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Store between 15º to 25ºC (59º to 77ºF)

Lot No and Expiration Dates - please see box and tube crimp

100% GUARANTEED

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Aloe vera gel, light mineral oil, white petrolatum

Stop Use and Ask Doctor If

The condition persists or gets worse
A rash or allergic reaction develops

Keep Out of Reach of Children

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

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, longer than 1 week unless directed by a doctor.

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

Package Label

Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Store between 15º to 25ºC (59º to 77ºF)

Lot No and Expiration Dates - please see box and tube crimp

100% GUARANTEED

Distributed By:

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Aloe vera gel, light mineral oil, white petrolatum

Stop Use and Ask Doctor If (Stop Use and Ask Doctor if)

The condition persists or gets worse
A rash or allergic reaction develops

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "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, longer than 1 week unless directed by a doctor. .", "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", "Active Ingredient": "Bacitracin Zinc 500 Units per gram", "Other Information": "Store between 15º to 25ºC (59º to 77ºF) Lot No and Expiration Dates - please see box and tube crimp 100% GUARANTEED Distributed By: Trifecta Pharmaceuticals USA ® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com", "Inactive Ingredients": "Aloe vera gel, light mineral oil, white petrolatum", "Stop Use and Ask Doctor if": "The condition persists or gets worse A rash or allergic reaction develops", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.478122 · Updated: 2026-03-14T23:08:44.584027