FDA.reportPublic FDA data

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

Manufacturer
Cardinal Health (Leader) 70000
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:36:51

Label at a glance#

ProductAntibiotic
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure10 sections

Indications and uses

First aid to help prevent infection in minor cuts scrapes burns

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc, USP 500 units
Polymyxin B sulfate, USP 10,000 units

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

SPL UNCLASSIFIED SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use longer than 1 week
  • condition persists or gets worse
  • a rash or other allergic reaction develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • Store at 15º-25ºC (59º-77ºF)
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

INACTIVE INGREDIENT SECTION

white petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO POLYSPORN® active ingredients*

Poly Bacitracin

Bacitracin Zinc USP

Polymyxin B Sulfate USP

First Aid

Antibiotic Ointment

For External Use Only

Help Prevent infection in Minor Cuts, Scrapes, and Burns

*This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Antibiotic Ointment
LEADER Antibiotic Ointment

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0070-1GM - Gram70000-0070f1b3ad48-9981-4187-8c78-0b2b08d7e97912021-09-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-007070000-0070-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5ac69c2d-e47d-4330-a7b6-60ba2aabbbd21280ce90-133a-472b-bfd7-107b9621deda2025-06-16WarningsExact identifier
spl id: 5ac69c2d-e47d-4330-a7b6-60ba2aabbbd2
spl set id: 1280ce90-133a-472b-bfd7-107b9621deda

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.