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

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units per gram

Medication Information

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.

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Purpose

First Aid Antibiotic

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

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

Description

Bacitracin Zinc 500 Units per gram

Section 51945-4

Package Label

Active Ingredient

Bacitracin Zinc 500 Units per gram

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

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.

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Purpose

First Aid Antibiotic

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

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

Section 51945-4 (51945-4)

Package Label

Active Ingredient

Bacitracin Zinc 500 Units per gram

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