FDA.reportPublic FDA data

FLUOCINONIDE 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE 4%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:55

Label at a glance#

ProductFLUOCINONIDE 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE 4%
Active ingredientFLUOCINONIDE, HYALURONATE SODIUM
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- 2086-3 FLUOCINONIDE USP 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE USP 4%. Cream 60 gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUOCINONIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2086-32021-01-29C16284748780-1ba0f9c33-591f-a910-e053-dadaa90a0b85FLUOCINONIDE 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2086-3FLUOCINONIDE 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE 4%60 g in 1 BOTTLE, PUMPCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2086FLUOCINONIDE 0.05% / HYALURONIC ACID SODIUM SALT 0.5% / NIACINAMIDE 4% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190523_89804cbd-4adb-9241-e053-2995a90a8a24.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-208672934-2086-3

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
FLUOCINONIDE2W4A77YPANACTIB
HYALURONATE SODIUMYSE9PPT4THACTIB

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
89804cbd-4adc-9241-e053-2995a90a8a2489804cbd-4adb-9241-e053-2995a90a8a242019-05-22Adverse reactionsExact identifier
spl id: 89804cbd-4adc-9241-e053-2995a90a8a24
spl set id: 89804cbd-4adb-9241-e053-2995a90a8a24

Reported adverse events (FAERS/openFDA)#

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