FDA.reportPublic FDA data

HYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025%

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 20:28:51

Label at a glance#

ProductHYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025%
Active ingredientHYDROQUINONE, TRETINOIN, TRIAMCINOLONE ACETONIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

mm

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

vv

Active, inactive

COMPONENTS

jj

NDC 72934-6120-2 HYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025% Emulsion 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cc

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRETINOIN 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
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-6120-22021-01-29C16284748780-1ba0f9c33-4ff4-a910-e053-dadaa90a0b85HYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-6120-2HYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025%30 g in 1 BOTTLE, PUMPEMULSION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-6120HYDROQUINONE 6% / TRETINOIN 0.05% / TRIAMCINOLONE 0.025% EMULSION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190521_8953d7fa-bfe2-9595-e053-2995a90abfbc.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
72934-612072934-6120-2

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
HYDROQUINONEXV74C1N1AEACTIB
TRETINOIN5688UTC01RACTIB
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
8953d7fa-bfe3-9595-e053-2995a90abfbc8953d7fa-bfe2-9595-e053-2995a90abfbc2019-05-20Adverse reactionsExact identifier
spl id: 8953d7fa-bfe3-9595-e053-2995a90abfbc
spl set id: 8953d7fa-bfe2-9595-e053-2995a90abfbc

Reported adverse events (FAERS/openFDA)#

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