SPL v1
SPL
SPL Set ID 49a73b0f-90d9-3a4b-e063-6294a90acfb0
Route
TOPICAL
Published
Effective Date 2021-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (3.5 mg) Bacitracin (500 [USP'U]) Polymyxin B (10000 [USP'U]) Lidocaine (40 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units Lidocaine 40 mg

Purpose

First aid antibiotic


Medication Information

Purpose

  • First aid antibiotic
Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units Lidocaine 40 mg

Uses

First aid to help prevent infection and temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns
Section 60561-8
  • store at room temperature( 68 to 77 F)
Warnings

For external use only

Questions

Call: 248 325 4231

Directions

adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

children under 2 years of age: ask a doctor

Do Not Use

  • do not use in the eyes
  • do not apply over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by your doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Ask A Doctor

Ask a doctor before use if you have

  • serious burns
  • deep or puncture wounds
  • animal bites
Active Ingredients
  • Bacitracin Zinc 400 units
  • Neomycin Sulfate 3.5mg
  • Polymyxin B Sulfate 5,000 units
  • Lidocaine 40 mg
Inactive Ingredient

Petrolatum

Principal Display Panel

Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • if you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days.
  • rash or other allergic reaction develops
Keep Out of the Reach of Children

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


Structured Label Content

Uses

First aid to help prevent infection and temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns
Section 60561-8 (60561-8)
  • store at room temperature( 68 to 77 F)
Purpose

  • First aid antibiotic
Warnings

For external use only

Questions

Call: 248 325 4231

Directions

adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

children under 2 years of age: ask a doctor

Do Not Use (Do not use)

  • do not use in the eyes
  • do not apply over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by your doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have

  • serious burns
  • deep or puncture wounds
  • animal bites
Active Ingredients
  • Bacitracin Zinc 400 units
  • Neomycin Sulfate 3.5mg
  • Polymyxin B Sulfate 5,000 units
  • Lidocaine 40 mg
Inactive Ingredient (Inactive ingredient)

Petrolatum

Principal Display Panel (Principal display panel)

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • if you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days.
  • rash or other allergic reaction develops
Keep Out of the Reach of Children (keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)