FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
Medsource Pharmaceuticals
Effective date
2018-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:28

Label at a glance#

ProductTriple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure9 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 400 units
Neomycin 3.5 mg
Polymyxin B sulfate, USP 5,000 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 if allergic to any of the ingredients

Do not use

OTC - DO NOT USE SECTION

  • 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

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 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 controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

INACTIVE INGREDIENT SECTION

white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Triple Antibiotic OinmentTriple Antibiotic Oinment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-640-012025-01-30C16284748780-12cef2736-61e7-d83d-e063-dadaa90ab31fTriple Antibiotic Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-640-01Triple Antibiotic1 in 1 CARTONOINTMENT11
45865-640-01Triple Antibiotic28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-640TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180728_72061450-572c-acb4-e053-2a95a90a0a99.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0179-34GM - Gram0472-0179f4ba8432-cf28-4d7e-86d8-ad3eaf115bdd12012-07-24
0472-0179-56GM - Gram0472-017902c98cec-6f68-468d-bf85-8c881eb854a212012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-64045865-640-01
0472-0179

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM

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
72061450-572d-acb4-e053-2a95a90a0a9972061450-572c-acb4-e053-2a95a90a0a992018-07-27WarningsExact identifier
spl id: 72061450-572d-acb4-e053-2a95a90a0a99
spl set id: 72061450-572c-acb4-e053-2a95a90a0a99

Reported adverse events (FAERS/openFDA)#

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