SPL v7
SPL
SPL Set ID 9c2d417e-6fec-42f4-9f0c-2ec79de9342d
Route
TOPICAL
Published
Effective Date 2023-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-15
Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg Polymyxin B Sulfate 5,000 units

Medication Information

Warnings and Precautions

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

Indications and Usage

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

Dosage and Administration

Clean the affected area

Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily

May be covered with a sterile bandage

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg Polymyxin B Sulfate 5,000 units

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately

Section 51727-6

White Petrolatum

Section 51945-4

Section 55105-1

First aid antibiotic

Active Ingredients (in Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

Polymyxin B Sulfate 5,000 units

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Clean the affected area

Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily

May be covered with a sterile bandage

Warnings and Precautions (34071-1)

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately

Section 51727-6 (51727-6)

White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First aid antibiotic

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

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

Polymyxin B Sulfate 5,000 units

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.255552 · Updated: 2026-03-14T23:10:48.259693