570-3125 bacitracin zinc ointment ndc 0404-0172-50

SPL v4

SPL

SPL Set ID eaf03943-c7a5-724e-e053-2995a90a3e6c

Route

topical

Published

Effective Date 2022-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bacitracin (500 [iU])

Inactive Ingredients

mineral oil paraffin white petrolatum

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

otc monograph drug active Since 2022-11-07

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc (500 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 room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat and humidity

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

Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Description

Bacitracin Zinc (500 units)

Questions?

1-888-396-2739 M-F 9-5 EST

Label

Bacitracin Zinc

Use(s)

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

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 (500 units)

When Using This Product

there are no side effects.

Stop Use and Ask A Doctor If

• The condition persists or gets worse

• A 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 Or Pharmacist Before Use If You Have

deep or puncture wounds, animal bites, or serious burns

Structured Label Content

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 room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat and humidity

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

Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Questions?

1-888-396-2739 M-F 9-5 EST

Label

Bacitracin Zinc

Use(s)

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

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 (500 units)

When Using This Product (When using this product)

there are no side effects.

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 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 Or Pharmacist Before Use If You Have (Ask a doctor or pharmacist before use if you have)

deep or puncture wounds, animal bites, or serious burns

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Label": "Bacitracin Zinc", "Use(s)": "First aid to help 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", "Questions?": "1-888-396-2739 M-F 9-5 EST", "Active Ingredient": "Bacitracin Zinc (500 units)", "Other Information": "• Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat and humidity • Tamper evident. Do not use if seal is torn, cut, or opened.", "Inactive Ingredients": "Mineral Oil, Paraffin, White Petrolatum", "When using this product": "there are no side effects.", "Stop use and ask a doctor if": "• The condition persists or gets worse • A 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 or pharmacist before use if you have": "deep or puncture wounds, animal bites, or serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.387582 · Updated: 2026-03-14T23:10:42.831626