Op

Op
SPL v1
SPL
SPL Set ID 03f3cce9-7e9f-90a6-e063-6294a90a660b
Route
TOPICAL
Published
Effective Date 2023-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (0.0035 g) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-08-28
Description

(in each gram) 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

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

Uses

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

Section 51945-4

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
  • in eyes over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor.

Other Information

Store at room temperature

Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate（neomycin 3.5 mg）

Polymyxin B sulfate (polymyxin B 5,000 units)

Inactive Ingredients

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If
  • if the condition persists or gets worse
  • a rash or other allergic reaction develops.

Keep Out of Reach of Children

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

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 and burns

Section 51945-4 (51945-4)

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)
  • in eyes over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor.

Other Information

Store at room temperature

Active Ingredients

(in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate（neomycin 3.5 mg）

Polymyxin B sulfate (polymyxin B 5,000 units)

Inactive Ingredients

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • if the condition persists or gets worse
  • a rash or other allergic reaction develops.

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.

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: 2026-02-15T12:01:13.241706 · Updated: 2026-03-14T23:01:17.657881