SPL v2
SPL
SPL Set ID 5bd568c4-3f52-07a2-e053-2991aa0a10db
Route
TOPICAL
Published
Effective Date 2018-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Polymyxin B (5000 [USP'U]) Neomycin (3.5 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-10-18
Description

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

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

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 50569-3

Ask a doctor before use if you have

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

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
Section 51945-4

ORIGINAL OINTMENT

NET WEIGHT: 0.33OZ (9.4g)

NDC#70648-555-01

Warnings
  • For external use only
Questions

www.ohiolabpharma.us

Directions

  • 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

Other Information
  • store at room temperature
Active Ingredients
  • Bacitracin Zinc 400 units
  • Neomycin Sulfate 3.5mg
  • Polymyxin B Sulfate 5,000 units
Inactive Ingredient

Petrolatum

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • condition persists or gets worse
  • 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.

Structured Label Content

Uses (USes)

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

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
Section 51945-4 (51945-4)

ORIGINAL OINTMENT

NET WEIGHT: 0.33OZ (9.4g)

NDC#70648-555-01

Purpose

First aid antibiotic

Warnings
  • For external use only
Questions (QUESTIONS)

www.ohiolabpharma.us

Directions

  • 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

Other Information (OTHER INFORMATION)
  • store at room temperature
Active Ingredients
  • Bacitracin Zinc 400 units
  • Neomycin Sulfate 3.5mg
  • Polymyxin B Sulfate 5,000 units
Inactive Ingredient

Petrolatum

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

Stop use and ask a doctor if

  • condition persists or gets worse
  • 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.017827 · Updated: 2026-03-14T22:55:19.604592