FDA.reportPublic FDA data

0.9g Triple Antibiotic

Manufacturer
Sled Distribution, LLC
Effective date
2022-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:05:05

Label at a glance#

Product0.9g Triple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure10 sections

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

USE

INDICATIONS & USAGE SECTION

First aid to help prevent infection in

minor cuts
scrapes
burns

Warning

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

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, Petrolatum, Purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81417-128-012025-11-24C16284748780-10191ceaa-6f9f-198a-e063-dbdaa90aec3edrug facts
81417-128-012023-07-28C16284748780-10191ceaa-6f9f-198a-e063-dbdaa90aec3edrug facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-1280.9G TRIPLE ANTIBIOTIC (BACITRACIN ZINC 400 UNITS) OINTMENT [SLED DISTRIBUTION, LLC]1Legacy NDC20220325_fa4eee0a-a6ca-4356-b8f5-7e03294a7be6.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
81417-12881417-128-01

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 ZINC89Y4M234ESACTIM
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
445c13f7-2a86-f4cd-e063-6394a90aa893fa4eee0a-a6ca-4356-b8f5-7e03294a7be62025-11-24WarningsExact identifier
spl set id: fa4eee0a-a6ca-4356-b8f5-7e03294a7be6

Reported adverse events (FAERS/openFDA)#

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