SPL v2
SPL
SPL Set ID 55e236e6-48b8-4391-b60f-7dcc5b5ecff7
Route
TOPICAL
Published
Effective Date 2013-06-08
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
Cocoa Butter Petrolatum Cottonseed Oil Olive Oil .alpha.-tocopherol Acetate Sodium Pyruvate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-10
Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B Sulfate 5000U

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration

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
Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B Sulfate 5000U

Section 42229-5

Other Information

  • Store at room temperature 20°C to 25°C (68°F to 77°C)
  • Lot No. Exp. Date: see crimp of tube
Section 50565-1

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

Section 50566-9

Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3

Ask a doctor before use on

  • on deep puncture wounds, animal bites, or serious burns
Section 50570-1

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
Section 51727-6

Inactive Ingredients

Cocoa butter, Petrolatum, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

Section 51945-4

Section 55105-1

Purpose

First Aid Antibiotic

Section 55106-9

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

Structured Label Content

Indications and Usage (34067-9)

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other Information

  • Store at room temperature 20°C to 25°C (68°F to 77°C)
  • Lot No. Exp. Date: see crimp of tube
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 50566-9 (50566-9)

Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor before use on

  • on deep puncture wounds, animal bites, or serious burns
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive Ingredients

Cocoa butter, Petrolatum, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

First Aid Antibiotic

Section 55106-9 (55106-9)

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.692092 · Updated: 2026-03-14T22:53:30.775793