FDA.reportPublic FDA data

FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:38

Label at a glance#

ProductFLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025%
Active ingredientFLUOCINOLONE ACETONIDE, MINOXIDIL, TRETINOIN
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

sdsd

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

cxcx

Active, inactive

COMPONENTS

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NDC 72934-4079-8. FLUOCINOLONE ACETONIDE USP 0.01% / MINOXIDIL USP 5% / TRETINOIN USP 0.025%. Solution 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
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRETINOIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct 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
72934-4079-82021-01-29C16284748780-1ba0f9c33-122a-a910-e053-dadaa90a0b858866e3d0-f0e4-3e63-e053-2a95a90aa63c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4079-8FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025%60 g in 1 BOTTLE, GLASSSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4079FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 5% / TRETINOIN 0.025% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190509_8866e3d0-f0e4-3e63-e053-2a95a90aa63c.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
72934-407972934-4079-8

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
FLUOCINOLONE ACETONIDE0CD5FD6S2MACTIB
MINOXIDIL5965120SH1ACTIB
TRETINOIN5688UTC01RACTIB

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
8866e3d0-f0e5-3e63-e053-2a95a90aa63c8866e3d0-f0e4-3e63-e053-2a95a90aa63c2019-05-08Adverse reactionsExact identifier
spl id: 8866e3d0-f0e5-3e63-e053-2a95a90aa63c
spl set id: 8866e3d0-f0e4-3e63-e053-2a95a90aa63c

Reported adverse events (FAERS/openFDA)#

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