FDA.reportPublic FDA data

Triple Antiobiotic

Manufacturer
Davemed Healthcare Co., Ltd.
Effective date
2019-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:24

Label at a glance#

ProductTriple Antiobiotic
Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN ZINC
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • clean affected area
  • apply small amount not more than 3 times daily
  • maybe covered with a sterile bandage
  • children under 2 years of age ask a doctor

INDICATIONS & USAGE SECTION

USES

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If ingested contact a poison control center right away.

OTC - ACTIVE INGREDIENT SECTION

NEOMYCIN

BACITRACIN

PRAMOXINE HCI

INACTIVE INGREDIENT SECTION

Petrolatum

OTC - PURPOSE SECTION

First Aid Antibiotic. For temporary relief of pain associated with minor burns.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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 OintmentPSN2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2

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
70897-003-012024-01-30C16284748780-11030e365-0a7a-111a-e063-dadaa90a10e2Triple Antiobiotic
70897-003-022024-01-30C16284748780-11030e365-0a7a-111a-e063-dadaa90a10e2Triple Antiobiotic
70897-003-032024-01-30C16284748780-11030e365-0a7a-111a-e063-dadaa90a10e2Triple Antiobiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70897-003-01Triple Antiobiotic0.9 g in 1 PACKETOINTMENT0.92
70897-003-02Triple Antiobiotic14.2 g in 1 TUBEOINTMENT14.22
70897-003-03Triple Antiobiotic28.4 g in 1 TUBEOINTMENT28.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70897-003TRIPLE ANTIOBIOTIC (TRIPLE ANTIBIOTIC OINTMENT) OINTMENT [DAVEMED HEALTHCARE CO., LTD.]2Legacy NDC, 3 package rows20190202_39d34a43-a672-6e9c-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
70897-00370897-003-01, 70897-003-02, 70897-003-03

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
POLYMYXIN B SULFATE19371312D4ACTIM
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
80d77b64-4575-2679-e053-2991aa0aa04539d34a43-a672-6e9c-e054-00144ff8d46c2019-02-01WarningsExact identifier
spl id: 80d77b64-4575-2679-e053-2991aa0aa045
spl set id: 39d34a43-a672-6e9c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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