Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID dfefde48-99ca-4443-b0bc-73e6c095210e
Route
TOPICAL
Published
Effective Date 2014-06-27
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
Methylparaben Mineral Oil Ceresin Petrolatum Propanediol Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-06-15
Description

Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B sulfate 5000U

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Description

Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B sulfate 5000U

Uses

first aid to help prevent infection in:  ■ minor cuts ■ scrapes ■ burns

Warnings

For external use only

Directions

■ clean the affected area and dry thoroughly ■ 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 ■ if you are allergic to any of the ingredients ■ longer than 1 week unless directed by a doctor ■ over large areas of the body

Package Label

Other Information

■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B sulfate 5000U

Inactive Ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Ask A doctor Before Use

■ on deep puncture wounds, animal bites, or serious burns

Keep Out of Reach of Children

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

Stop Use and Consult A Doctor If

■ the condition persists worsens ■ a rash or other allergic reaction develops

Structured Label Content

Uses

first aid to help prevent infection in:  ■ minor cuts ■ scrapes ■ burns

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Warnings

For external use only

Directions

■ clean the affected area and dry thoroughly ■ 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 ■ if you are allergic to any of the ingredients ■ longer than 1 week unless directed by a doctor ■ over large areas of the body

Package Label

Other Information

■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

Active Ingredients (Active ingredients)

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B sulfate 5000U

Inactive Ingredients (Inactive ingredients)

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Ask A doctor Before Use (Ask a doctor before use)

■ on deep puncture wounds, animal bites, or serious burns

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 Consult A Doctor If (Stop use and consult a doctor if)

■ the condition persists worsens ■ a rash or other allergic reaction develops

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:09.193940 · Updated: 2026-03-14T22:54:23.335310