SPL v1
SPL
SPL Set ID 3622b293-f4bc-af1d-e063-6394a90a1c1b
Route
TOPICAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-30

Description

Bacitracin Zinc 400 Units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 Units

Purpose

Triple Antibiotic Ointment to treat minor cuts, scrapes, and burns.


Medication Information

Purpose

Triple Antibiotic Ointment to treat minor cuts, scrapes, and burns.

Description

Bacitracin Zinc 400 Units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 Units

Uses

First aid to help prevent infection in minor:

  • Cuts
  • Scrapes
  • Burns
Warnings

For external use only.

Do Not Use:

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
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 bandageDirections
Questions?

Call 1-760-642-2638

Ask A Doctor

Ask a doctor before use if you have:

  • Deep or Puncture Wounds
  • Animal Bites
  • Serious Burns

Stop use and ask a doctor before use if:

  • Condition persists or gets worse
  • You need to use longer than 1 week
  • A rash or other allergic reaction develops
Package Label

Other Information

Store at 68° to 77°F (20° to 25°C)

Active Ingredients

Bacitracin Zinc 400 Units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 Units

Inactive Ingredients

Light Mineral Oil, White petrolatum

Keep Out of Reach of Childern

If swallowed, get medical help or contact a Posison Control Center immediately.


Structured Label Content

Uses

First aid to help prevent infection in minor:

  • Cuts
  • Scrapes
  • Burns
Purpose

Triple Antibiotic Ointment to treat minor cuts, scrapes, and burns.

Warnings

For external use only.

Do Not Use:

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
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 bandageDirections
Questions?

Call 1-760-642-2638

Ask A Doctor (Ask a Doctor)

Ask a doctor before use if you have:

  • Deep or Puncture Wounds
  • Animal Bites
  • Serious Burns

Stop use and ask a doctor before use if:

  • Condition persists or gets worse
  • You need to use longer than 1 week
  • A rash or other allergic reaction develops
Package Label

Other Information

Store at 68° to 77°F (20° to 25°C)

Active Ingredients

Bacitracin Zinc 400 Units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 Units

Inactive Ingredients

Light Mineral Oil, White petrolatum

Keep Out of Reach of Childern (Keep out of reach of childern)

If swallowed, get medical help or contact a Posison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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