FDA.reportPublic FDA data

HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.05%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:50

Label at a glance#

ProductHYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.05%
Active ingredientTRETINOIN, HYDROCORTISONE, HYDROQUINONE
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- 6108- HYDROCORTISONE USP 0.5% / HYDROQUINONE USP 8% / TRETINOIN USP 0.05%. Emulsion 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
TRETINOIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-6108-22021-01-29C16284748780-1ba0f9c33-270a-a910-e053-dadaa90a0b85HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-6108-2HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.05%30 g in 1 BOTTLE, PUMPEMULSION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-6108HYDROCORTISONE 0.5% / HYDROQUINONE 8% / TRETINOIN 0.05% EMULSION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190518_891bcb9a-e940-5731-e053-2995a90a2dc6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-6108-2GM - Gram72934-61088e44b1e2-d824-4f5c-be06-6c44d7039c5012020-03-10

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
72934-610872934-6108-2

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
TRETINOIN5688UTC01RACTIB
HYDROCORTISONEWI4X0X7BPJACTIB
HYDROQUINONEXV74C1N1AEACTIB

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
891bcb9a-e941-5731-e053-2995a90a2dc6891bcb9a-e940-5731-e053-2995a90a2dc62019-05-17Adverse reactionsExact identifier
spl id: 891bcb9a-e941-5731-e053-2995a90a2dc6
spl set id: 891bcb9a-e940-5731-e053-2995a90a2dc6

Reported adverse events (FAERS/openFDA)#

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