FDA.reportPublic FDA data

PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:44

Label at a glance#

ProductPENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1%
Active ingredientPENTOXIFYLLINE, TRIAMCINOLONE ACETONIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ss

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

adad

Active, inactive

COMPONENTS

xx

NDC 72934- 1169-2 PENTOXIFYLLINE USP 0.5% / TRIAMCINOLONE ACETONIDE USP 0.1%. Gel 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

xx

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PENTOXIFYLLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRIAMCINOLONE ACETONIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
06331747-0b00-4cea-707f-3d3bfb5d208dProduct name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1169-22021-01-29C16284748780-1ba0f9c33-3af8-a910-e053-dadaa90a0b85PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1169-2PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1169PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190515_88dee26d-be09-5ae2-e053-2995a90ac52c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-116972934-1169-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTOXIFYLLINESD6QCT3TSUACTIB
TRIAMCINOLONE ACETONIDEF446C597KAACTIB

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
88dee26d-be0a-5ae2-e053-2995a90ac52c88dee26d-be09-5ae2-e053-2995a90ac52c2019-05-14Adverse reactionsExact identifier
spl id: 88dee26d-be0a-5ae2-e053-2995a90ac52c
spl set id: 88dee26d-be09-5ae2-e053-2995a90ac52c

Reported adverse events (FAERS/openFDA)#

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