First Aid Antibiotic Ointment

SPL v2

SPL

SPL Set ID f44ab989-c618-1831-e053-2995a90adc8e

Route

TOPICAL

Published

Effective Date 2023-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (400 U) Neomycin (3.5 mg) Polymyxin B (5000 U)

Inactive Ingredients

Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Uses

first aid to help decrease the risk of infection in minor

• cuts • scrapes • 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

• for more than 1 week unless directed by a doctor

• in the eyes

• over large areas of the body

Drug Facts

Other Information

• Store at room temperature

Package Labeling:

Inactive Ingredients

Mineral oil, petrolatum, purified water

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If

• condition persists or gets worse

• rash or other allergic reaction develops

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have

• deep or puncture wounds • serious burns • animal bites

Structured Label Content

Uses

first aid to help decrease the risk of 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 (Do not use)

• for more than 1 week unless directed by a doctor

• in the eyes

• over large areas of the body

Drug Facts

Other Information (Other information)

• Store at room temperature

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Mineral oil, petrolatum, purified water

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.

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

• condition persists or gets worse

• rash or other allergic reaction develops

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or puncture wounds • serious burns • animal bites

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "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": "U", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help decrease the risk of 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": "• for more than 1 week unless directed by a doctor • in the eyes • over large areas of the body", "Other information": "• Store at room temperature", "Inactive ingredients": "Mineral oil, petrolatum, purified water", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Stop use and ask a doctor if ": "• condition persists or gets worse • rash or other allergic reaction develops", "Active ingredients (in each gram)": "Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) Polymyxin B sulfate (polymyxin B 5,000 units)", "Ask a doctor before use if you have": "• deep or puncture wounds • serious burns • animal bites"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.870177 · Updated: 2026-03-14T23:01:48.065872