570-3130 Triple Antibiotic Ndc 0404-0171-50

SPL v4

SPL

SPL Set ID eadb847e-aefe-41cf-e053-2995a90af2cd

Route

TOPICAL

Published

Effective Date 2022-11-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polymyxin B (50000 [iU]) Neomycin (5 mg) Bacitracin (400 [iU])

Inactive Ingredients

White Petrolatum

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-04

Description

Bacitracin Zinc (400 units) Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin) Polymyxin B Sulfate 5000 Units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (400 units) Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin) Polymyxin B Sulfate 5000 Units

Label

Use(s)

First aid to prevent infection in minor cuts, scrapes, and burns

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

• In the eyes or over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Active Ingredient

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

Polymyxin B Sulfate 5000 Units

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if seal if torn, cut, or opened.

Inactive Ingredients

White Petrolatum

Stop Use and Ask A Doctor If

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep Our of Reach of Children

If swallowed, get medical help or contract a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

Deep or puncture wounds, animal bites, or serious burns.

Structured Label Content

Label

Use(s)

First aid to prevent infection in minor cuts, scrapes, and 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 (Do not use)

• In the eyes or over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Active Ingredient

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

Polymyxin B Sulfate 5000 Units

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if seal if torn, cut, or opened.

Inactive Ingredients

White Petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep Our of Reach of Children (Keep our of reach of children)

If swallowed, get medical help or contract 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, or serious burns.

Advanced Ingredient Data

[{"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "50000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "First aid to prevent infection in minor cuts, scrapes, and 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": "• In the eyes or over large areas of the body • If you are allergic to any of the ingredients • Longer than 1 week unless directed by a doctor", "Active Ingredient": "Bacitracin Zinc (400 units) Neomycin Sulfate 5mg (Equivalent to 3.5mg Neomycin) Polymyxin B Sulfate 5000 Units", "Other Information": "• Store at room temperature 15º-30ºC (59º-86ºF) • Tamper evident. Do not use if seal if torn, cut, or opened.", "Inactive Ingredients": "White Petrolatum", "Stop use and ask a doctor if": "• The condition persists or gets worse • A rash or other allergic reaction develops", "Keep our of reach of children": "If swallowed, get medical help or contract a Poison Control Center (1-800-222-1222) right away.", "Ask a doctor before use if you have": "Deep or puncture wounds, animal bites, or serious burns."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.386199 · Updated: 2026-03-14T23:10:42.831626