FDA.reportPublic FDA data

HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:46

Label at a glance#

ProductHYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%
Active ingredientUREA, HYALURONATE SODIUM, TACROLIMUS
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

zz

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

xx

Active, inactive

COMPONENTS

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NDC 72934- 2097-2 HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS USP 0.1% / UREA USP 20%. Cream 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TACROLIMUS ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
df369ad4-19d8-393a-de46-8c6255b8b360Product name820251120
d2a74186-7b26-dbcc-9435-50b3d0be14abProduct name220250114
a64835ae-fa9d-41d8-9a93-36828ba72b96Product name320190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8badProduct name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2097-22021-01-29C16284748780-1ba0f9c33-26c5-a910-e053-dadaa90a0b85HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2097-2HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2097HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190517_89036512-64f6-224b-e053-2a95a90a8068.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-209772934-2097-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WACTIB
HYALURONATE SODIUMYSE9PPT4THACTIB
TACROLIMUSWM0HAQ4WNMACTIM

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
89036512-64f7-224b-e053-2a95a90a806889036512-64f6-224b-e053-2a95a90a80682019-05-16Adverse reactionsExact identifier
spl id: 89036512-64f7-224b-e053-2a95a90a8068
spl set id: 89036512-64f6-224b-e053-2a95a90a8068

Reported adverse events (FAERS/openFDA)#

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