SPL v1
SPL
SPL Set ID 37a3916f-cc1a-41a0-e063-6394a90a35ed
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16
Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equilvant to 3.5mg of Neomycin Base) Polymyxin B Sulfate 5,000 units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equilvant to 3.5mg of Neomycin Base) Polymyxin B Sulfate 5,000 units

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 51945-4

Warnings

Warnings

For External Use Only

Directions

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

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
Active Ingredients

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equilvant to 3.5mg of Neomycin Base)

Polymyxin B Sulfate 5,000 units

Inactive Ingredient

Inactive Ingredient: White Petrolatum

Ask A Doctor Before Use

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds
Keep Out of Reach of Children

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 51945-4 (51945-4)

Purpose

First Aid Antibiotic

Warnings

Warnings

For External Use Only

Directions

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)

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • over large areas of the body
Active Ingredients

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equilvant to 3.5mg of Neomycin Base)

Polymyxin B Sulfate 5,000 units

Inactive Ingredient

Inactive Ingredient: White Petrolatum

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

Ask a doctor before use if you have:

  • animal bites
  • serious burns
  • deep or puncture wounds
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:19.622944 · Updated: 2026-03-14T23:09:01.566522