FDA.reportPublic FDA data

Ointment

Manufacturer
Sled Distribution, LLC
Effective date
2021-01-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 22:57:30

Label at a glance#

ProductSingle 0.9g Triple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure8 sections

Indications and uses

First aid to help prevent infection in minor cuts scrapes burns

Dosage and administration

Clean the 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

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neoycin sulfate (neoycin 3.5 mg)

Polymyxin B sulfate

(polymyxin B 5,000 units)

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • on deep or puncture wounds, animal bites, or serious burns

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition persists or gets worse
  • a rash or other allergic reaction develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the 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

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, Petrolatum, Purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OINTMENT

BoxBoxLabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81417-108-012025-11-24C16284748780-1f386c649-a69c-0266-e053-dadaa90a7c1aOintment
81417-108-012023-01-30C16284748780-1f386c649-a69c-0266-e053-dadaa90a7c1aOintment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-108SINGLE 0.9G TRIPLE ANTIBIOTIC (BACITRACIN ZINC 400 UNITS) OINTMENT [SLED DISTRIBUTION, LLC]10Legacy NDC20210109_2e03e7a8-e270-4a1f-9a54-8536ebe5c07b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-10881417-108-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIB
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT

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
445bc78f-c62c-69b6-e063-6294a90a89752e03e7a8-e270-4a1f-9a54-8536ebe5c07b2025-11-24WarningsExact identifier
spl set id: 2e03e7a8-e270-4a1f-9a54-8536ebe5c07b

Reported adverse events (FAERS/openFDA)#

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