Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 71592776-407b-489c-8cdb-8c0573d844f8
Route
TOPICAL
Published
Effective Date 2013-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 U) Neomycin (3.5 mg) Polymyxin B (5000 U)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-02-05
Description

Bacitracin Zinc............400 units Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate ....5000 units

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc............400 units Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate ....5000 units

Uses

First aid to prevent infection in

  • Minor cuts
  • Scrapes
  • Burns

Warnings

For External Use Only.

Directions
  • Clean the affected area
  • Apply small amount of this product(an amount equal to the surface area of the tip of the 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
  • Over large areas of the body
  • Longer than 1 week unless directed by a doctor
  • Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

Other Information
  • Store at controlled room temperature 15 o- 30 oC(59 o--86 oF)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut or opened.

Inactive Ingredients

White Soft Paraffin

Principal Display Panel

Stop Use and Ask A Doctor If
  • The condition persists or gets worse
  • A rash or allergic reaction develops

Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Centre right away

Active Ingredients(in Each Gram)

Bacitracin Zinc............400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate ....5000 units

Structured Label Content

Uses

First aid to prevent infection in

  • Minor cuts
  • Scrapes
  • Burns

Purpose

First Aid Antibiotic

Warnings

For External Use Only.

Directions
  • Clean the affected area
  • Apply small amount of this product(an amount equal to the surface area of the tip of the 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
  • Longer than 1 week unless directed by a doctor
  • Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns

Other Information (Other information)
  • Store at controlled room temperature 15 o- 30 oC(59 o--86 oF)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet is torn, cut or opened.

Inactive Ingredients

White Soft Paraffin

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • The condition persists or gets worse
  • A rash or 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 Centre right away

Active Ingredients(in Each Gram) (Active Ingredients(in each gram))

Bacitracin Zinc............400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate ....5000 units

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.862270 · Updated: 2026-03-14T23:09:05.302478