Elixir Bacitracin Zinc Ointment

SPL v2

SPL

SPL Set ID 15e31a2a-01b5-4598-850f-4d0348086b4b

Route

TOPICAL

Published

Effective Date 2025-10-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

Paraffin Mineral Oil White Petrolatum Lanolin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Bacitracin zinc 500 units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin zinc 500 units

Uses

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) 1 to 3 times daily.

• May be covered with a sterile bandage.

Do Not Use

• in the eyes

• if you are allergic to any of the ingredients

• over large areas of the body or for longer than 1 week unless directed by a doctor

Other Information

Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.

Inactive Ingredients

hard paraffin, mineral oil, lanolin, white soft paraffin.

Principal Display Panel

^*Compare to the active ingredient in ACTAVIS BACIRACIN ZINC OINTMENT USP

NDC: 84546-0002-01

Bacitracin Zinc Ointment USP

First AID ANTIBIOTIC

Elixir

Net Wt. 1 oz, (28.3 gm)

Help prevent infection in minor cuts, scrapes & burns

Reorder No: MRP-XXXX

Stop Use and Ask A Doctor If

• 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 right away.

Active Ingredient (in Each Gram)

Bacitracin zinc 500 units

Ask A Doctor Before Use in Case Of

• deep or puncture wounds

• animal bites

• serious burns

Structured Label Content

Uses

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) 1 to 3 times daily.

• May be covered with a sterile bandage.

Do Not Use (Do not use)

• in the eyes

• if you are allergic to any of the ingredients

• over large areas of the body or for longer than 1 week unless directed by a doctor

Other Information (Other information)

Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.

Inactive Ingredients (Inactive ingredients)

hard paraffin, mineral oil, lanolin, white soft paraffin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

^*Compare to the active ingredient in ACTAVIS BACIRACIN ZINC OINTMENT USP

NDC: 84546-0002-01

Bacitracin Zinc Ointment USP

First AID ANTIBIOTIC

Elixir

Net Wt. 1 oz, (28.3 gm)

Help prevent infection in minor cuts, scrapes & burns

Reorder No: MRP-XXXX

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

• 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 right away.

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

Bacitracin zinc 500 units

Ask A Doctor Before Use in Case Of (Ask a doctor before use in case of)

• deep or puncture wounds

• animal bites

• serious burns

Advanced Ingredient Data

[{"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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) 1 to 3 times daily. • May be covered with a sterile bandage.", "Do not use": "• in the eyes • if you are allergic to any of the ingredients • over large areas of the body or for longer than 1 week unless directed by a doctor", "Other information": "Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.", "Inactive ingredients": "hard paraffin, mineral oil, lanolin, white soft paraffin.", "PRINCIPAL DISPLAY PANEL": "* Compare to the active ingredient in ACTAVIS BACIRACIN ZINC OINTMENT USP NDC: 84546-0002-01 Bacitracin Zinc Ointment USP First AID ANTIBIOTIC Elixir Net Wt. 1 oz, (28.3 gm) Help prevent infection in minor cuts, scrapes & burns Reorder No: MRP-XXXX", "Stop use and ask a doctor if": "• 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 right away.", "Active Ingredient (in each gram)": "Bacitracin zinc 500 units", "Ask a doctor before use in case of": "• deep or puncture wounds • animal bites • serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:01.881875 · Updated: 2026-03-14T23:13:35.542610