triple antibiotic ointment (bacitracin zinc, neomycin sulfate, polymyxin b sulfate)

SPL v1

SPL

SPL Set ID 32df5cca-77bc-45d2-b1f6-2cfdfc371ea9

Route

topical

Published

Effective Date 2025-01-28

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U])

Inactive Ingredients

white petrolatum

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-01-29

Purpose

First aid antibiotic

Description

Active Ingredient (in each gram) Bacitracin Zinc, USP 400 units Neomycin 3.5mg Polymyxin B Sulfate, USP 5,000 units

Medication Information

Warnings

For external use only.

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 at 15°-30°C (59°-86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Description

Active Ingredient (in each gram) Bacitracin Zinc, USP 400 units Neomycin 3.5mg Polymyxin B Sulfate, USP 5,000 units

Principal Display Panel

Use(s)

First aid to help prevent infection in minor

cuts
scrapes
burns

Do Not Use

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

Inactive Ingredient

white petrolatum

Active Ingredient(s)

Active Ingredient (in each gram)

Bacitracin Zinc, USP 400 units

Neomycin 3.5mg

Polymyxin B Sulfate, USP 5,000 units

Questions Or Comments?

Call 1-833-285-4151 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other 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 A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns

Structured Label Content

Warnings (WARNINGS)

For external use only.

Purpose (PURPOSE)

First aid antibiotic

Directions (DIRECTIONS)

Other Information (OTHER INFORMATION)

■ store at 15°-30°C (59°-86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use(s) (USE(S))

First aid to help prevent infection in minor

cuts
scrapes
burns

Do Not Use (DO NOT USE)

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

Inactive Ingredient (INACTIVE INGREDIENT)

white petrolatum

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active Ingredient (in each gram)

Bacitracin Zinc, USP 400 units

Neomycin 3.5mg

Polymyxin B Sulfate, USP 5,000 units

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other 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 A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

■ deep or puncture wounds

■ animal bites

■ serious burns

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "First aid to help prevent infection in minor cuts scrapes burns", "PURPOSE": "First aid antibiotic", "WARNINGS": "For external use only.", "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", "DO NOT USE": "if you are allergic to any of the ingredients in the eyes over large areas of the body", "OTHER INFORMATION": "■ store at 15°-30°C (59°-86°F). Protect from freezing. ■ before using any medication, read all label directions. Keep carton, it contains important information.", "INACTIVE INGREDIENT": "white petrolatum", "ACTIVE INGREDIENT(S)": "Active Ingredient (in each gram) Bacitracin Zinc, USP 400 units Neomycin 3.5mg Polymyxin B Sulfate, USP 5,000 units", "QUESTIONS OR COMMENTS?": "Call 1-833-285-4151 Monday-Friday 9AM-5PM EST", "STOP USE AND ASK A DOCTOR IF": "■ you need to use longer than one week ■ condition persists or gets worse ■ rash or other 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 A DOCTOR BEFORE USE IF YOU HAVE": "■ deep or puncture wounds ■ animal bites ■ serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.515670 · Updated: 2026-03-14T23:07:26.290118