Package Labeling

Package Labeling
SPL v5
SPL
SPL Set ID 454bfeed-f58f-003a-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2013-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-11-01
Description

Active Ingredients (in each gram)         Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Active Ingredients (in each gram)         Bacitracin 400 units Neomycin 3.5 mg Polymyxin B 5,000 units

Uses

first aid to help prevent infection in minor:

• cuts    • scrapes   • burns

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Warnings

For external use only.

Directions

• clean the affected area • apply a small amount of 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

• if you are allergic to any of the ingredients



• in the eyes



• over large areas of the body

Drug Facts

Active Ingredients (in each gram)        

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Other Information

•store at controlled room temperature

• prior to initial use, please prime pump by depressing multiple times

Inactive Ingredients

white petrolatum

Questions Or Comments?

1-800-635-3696

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 • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Ask A Doctor Before Use If You Have

• deep or puncture wounds • animal bites • serious burns

Structured Label Content

Uses

first aid to help prevent infection in minor:

• cuts    • scrapes   • burns

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose

First Aid Antibiotic

Warnings

For external use only.

Directions

• clean the affected area • apply a small amount of 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)

• if you are allergic to any of the ingredients



• in the eyes



• over large areas of the body

Drug Facts

Active Ingredients (in each gram)        

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Other Information (Other information)

•store at controlled room temperature

• prior to initial use, please prime pump by depressing multiple times

Inactive Ingredients

white petrolatum

Questions Or Comments? (Questions or Comments?)

1-800-635-3696

Stop Use and Ask A Doctor If (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 • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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

• deep or puncture wounds • animal bites • serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:14.362547 · Updated: 2026-03-14T22:54:35.350687