MedPath

Antibiotic

Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

Approved
Approval ID

9a092f24-65b2-4b57-8103-265ea3e03311

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Walgreens

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-0018
Application NumberM004
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (4)

BACITRACIN ZINCActive
Quantity: 500 [iU] in 1 g
Code: 89Y4M234ES
Classification: ACTIM
POLYMYXIN B SULFATEActive
Quantity: 10000 [iU] in 1 g
Code: 19371312D4
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Package label

![Bacitracin Zinc, USP 500 units, Neomycin 3.5 mg, Polymyxin B Sulfate, USP 10,000 units](/dailymed/image.cfm?name=antibiotic-maximum-strength-ointment- delisted-1.jpg&id=895826)

WALGREENS Antibiotic Ointment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/2/2025

Other information

  • Store at 15º-30ºC (59º-86ºF) Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units
Neomycin 3.5 mg
Polymyxin B sulfate, USP 10,000 units

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Purpose

First aid antibiotic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

Warnings

For external use only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than one week
  • condition persists or gets worse
  • a rash or other allergic reaction develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

Directions

  • clean affected area
  • 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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2025

Inactive ingredient

white petrolatum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2025

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Antibiotic - FDA Drug Approval Details