Fl-2009 - DailyMed Details

Fl-2009

SPL v3

SPL

SPL Set ID 0f509f96-a083-37d1-e063-6394a90a622c

Route

TOPICAL

Published

Effective Date 2024-01-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU])

Inactive Ingredients

White Petrolatum

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-26

Description

Bacitracin Zinc 400 units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 400 units

Label

FL-2009

Use(s)

First aid to help 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 apply 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?

1-888-900-2920 Monday - Friday 8AM-4PM PST.

Other Information

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

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

Inactive Ingredient

White Petrolatum

Ask A Doctor Before Use If

You have deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If

• The condition perists 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.

Active Ingredient (in Each Gram)

Bacitracin Zinc 400 units

Structured Label Content

Label

FL-2009

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 (Do not use)

• In the eyes or apply 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?

1-888-900-2920 Monday - Friday 8AM-4PM PST.

Other Information

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

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

Inactive Ingredient

White Petrolatum

Ask A Doctor Before Use If (Ask a doctor before use if)

You have deep or puncture wounds, animal bites, or serious burns

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

• The condition perists 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.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin Zinc 400 units

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Label": "FL-2009", "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 apply 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?": "1-888-900-2920 Monday - Friday 8AM-4PM PST.", "Other Information": "• Store at room temperature between 15º-30ºC (59º-86ºF) • Tamper evident. Do not use if packet is torn, cut, or opened.", "Inactive Ingredient": "White Petrolatum", "Ask a doctor before use if": "You have deep or puncture wounds, animal bites, or serious burns", "Stop use and ask a doctor if": "• The condition perists 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.", "Active Ingredient (in each gram)": "Bacitracin Zinc 400 units"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.532313 · Updated: 2026-03-14T23:11:23.873993