globe bacitracin zinc ointment

SPL v1

SPL

SPL Set ID 4352c453-a89c-a2b9-e063-6294a90a61f3

Route

topical

Published

Effective Date 2025-06-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bacitracin (500 [USP'U])

Inactive Ingredients

paraffin white petrolatum mineral oil

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-06-05

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units

Medication Information

Warnings

For External Use Only.

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Purpose

First Aid Antibiotic

Directions

Clean the affected area and dry thoroughly.
Apply a small amount of the 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

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Mineral oil, white petrolatum, paraffin

Description

Bacitracin Zinc 500 Units

Section 51945-4

Questions

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 1013SL

Do Not Use

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

Active Ingredient

Bacitracin Zinc 500 Units

Storage Information

Store at room temperature 15° to 25°C (59° to 77°F).

Ask Doctor Before Use If

you have deep or puncture wounds, aniimal bites or serious burns.

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.

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Purpose

First Aid Antibiotic

Directions

Clean the affected area and dry thoroughly.
Apply a small amount of the 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

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Inactive Ingredients

Mineral oil, white petrolatum, paraffin

Section 51945-4 (51945-4)

Questions

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 1013SL

Do Not Use

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

Active Ingredient

Bacitracin Zinc 500 Units

Storage Information

Store at room temperature 15° to 25°C (59° to 77°F).

Ask Doctor Before Use If (ASK DOCTOR BEFORE USE IF)

you have deep or puncture wounds, aniimal bites or serious burns.

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": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}]

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.", "Questions": "Call 1-888-296-9067 Fax: 1-888-878-3609 Online: www.trifecta-pharma.com Reorder No. 1013SL", "Directions": "Clean the affected area and dry thoroughly. Apply a small amount of the 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", "Do Not Use": "in eyes over large areas of the body if you are allergic to any of the ingredients", "Active Ingredient": "Bacitracin Zinc 500 Units", "Other Information": "Distributed By: Trifecta Pharmaceuticals USA® Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com", "Storage Information": "Store at room temperature 15° to 25°C (59° to 77°F).", "Inactive Ingredients": "Mineral oil, white petrolatum, paraffin", "ASK DOCTOR BEFORE USE IF": "you have deep or puncture wounds, aniimal bites or serious burns.", "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: 2026-02-15T12:09:00.955814 · Updated: 2026-03-14T23:13:34.159935