FDA.reportPublic FDA data

FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:53

Label at a glance#

ProductFLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%
Active ingredientLIDOCAINE HYDROCHLORIDE, FLUOCINOLONE ACETONIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 1083-3 FLUOCINOLONE ACETONIDE USP 0.025% / LIDOCAINE HCL MONOHYDRATE USP 1%. Gel 60 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUOCINOLONE ACETONIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1083-32021-01-29C16284748780-1ba0f9c33-446a-a910-e053-dadaa90a0b85FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1083-3FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1%60 g in 1 BOTTLE, PUMPGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1083FLUOCINOLONE ACETONIDE 0.025% / LIDOCAINE HCL MONOHYDRATE 1% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190521_8957cf62-ea51-3447-e053-2a95a90a536a.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-108372934-1083-3

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
FLUOCINOLONE ACETONIDE0CD5FD6S2MACTIB

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
8957cf62-ea52-3447-e053-2a95a90a536a8957cf62-ea51-3447-e053-2a95a90a536a2019-05-20Adverse reactionsExact identifier
spl id: 8957cf62-ea52-3447-e053-2a95a90a536a
spl set id: 8957cf62-ea51-3447-e053-2a95a90a536a

Reported adverse events (FAERS/openFDA)#

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