Major Triple Antibiotic Ointment

SPL v5

SPL

SPL Set ID a6cc3fbc-6302-4033-e053-2a95a90a19f0

Route

TOPICAL

Published

Effective Date 2020-05-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Neomycin (3.5 mg) Bacitracin (400 [USP'U]) Polymyxin B (5000 [USP'U])

Inactive Ingredients

Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-20

Description

Bacitracin Zinc 400 Units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 400 Units

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Section 34088-5

Warnings

For External Use Only.

Packaging

Questions

Call 1-800-616-2471

Directions

Clean the affected area
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 400 Units

Active Ingredient

Neomycin 3.5 mg

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Inactive Ingredients

mineral oil and white petrolatum

Stop Use and Ask Doctor If

If you need to use longer than 1 week
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 (1-800-222-1222) right away.

Ask Doctor Before Use If You Have

deep or puncture wounds

animal bites

serious burns

Structured Label Content

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Section 34088-5 (34088-5)

Purpose

First Aid Antibiotic

Warnings

For External Use Only.

Packaging

Questions

Call 1-800-616-2471

Directions

Clean the affected area
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 400 Units

Active Ingredient (Active ingredient)

Neomycin 3.5 mg

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Inactive Ingredients

mineral oil and white petrolatum

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

If you need to use longer than 1 week
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 (1-800-222-1222) right away.

Ask Doctor Before Use If You Have (Ask Doctor before use if you have)

deep or puncture wounds

animal bites

serious burns

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "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 1-800-616-2471", "Directions": "Clean the affected area 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 400 Units", "Active ingredient": "Neomycin 3.5 mg", "Other Information": "Tamper evident. Do not use if packet is torn, cut or opened. Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive Suite 233 Livonia, MI 48152 Product of USA", "Storage Information": "Avoid excessive heat and humidity Store at room temperature 15° to 30°C (59° to 86°F).", "Inactive Ingredients": "mineral oil and white petrolatum", "Stop Use and Ask Doctor if": "If you need to use longer than 1 week 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 (1-800-222-1222) right away.", "Ask Doctor before use if you have": "deep or puncture wounds animal bites serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:34.686828 · Updated: 2026-03-14T23:03:44.598062