FDA.reportPublic FDA data

Triple Antibiotic Ointment

Manufacturer
Sabel Med LLC
Effective date
2016-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:50

Label at a glance#

ProductAftate Triple Antibiotic
Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN ZINC
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

dosage directionsdosage directions

INDICATIONS & USAGE SECTION

usesuses

WARNINGS SECTION

warnings part 2warnings part 2warnings part 1warnings part 1

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reachkeep out of reach

OTC - ACTIVE INGREDIENT SECTION

active ingredientsactive ingredients

INACTIVE INGREDIENT SECTION

inactive ingredientinactive ingredient

OTC - PURPOSE SECTION

purposepurpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

princple displayprincple display

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
70356-101-012020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment
70356-101-052020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment
70356-101-332020-01-31C16284748780-19d75b9d0-ceb9-f424-e053-dadaa90a57ceTriple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70356-101-01Aftate Triple Antibiotic28 g in 1 TUBEOINTMENT281
70356-101-05Aftate Triple Antibiotic14 g in 1 TUBEOINTMENT141
70356-101-33Aftate Triple Antibiotic9.4 g in 1 TUBEOINTMENT9.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70356-101AFTATE TRIPLE ANTIBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [SABEL MED LLC]1Legacy NDC, 3 package rows20160501_2f6e9a84-895c-492d-e054-00144ff8d46c.zip

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
70356-10170356-101-01, 70356-101-05, 70356-101-33

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
POLYMYXIN B SULFATE19371312D4ACTIM
PETROLATUM4T6H12BN9UIACT
NEOMYCIN SULFATE057Y626693ACTIM
BACITRACIN ZINC89Y4M234ESACTIM

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
2f6e9a84-895d-492d-e054-00144ff8d46c2f6e9a84-895c-492d-e054-00144ff8d46c2016-04-01WarningsExact identifier
spl id: 2f6e9a84-895d-492d-e054-00144ff8d46c
spl set id: 2f6e9a84-895c-492d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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