FDA.reportPublic FDA data

BENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025%

Manufacturer
Sincerus, Florida, LLC | Sincerus Florida, LLC
Effective date
2020-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:51

Label at a glance#

ProductBENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025%
Active ingredientBENZOYL PEROXIDE, NIACINAMIDE, TRETINOIN
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use.

INSTRUCTIONS FOR USE SECTION

cc

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

dd

Active/ Inactive

COMPONENTS

123123

NDC 72934-1021-2 BENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025% GEL 30 gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gg

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1021-22022-01-28C16284748780-1d6a99b39-db08-a426-e053-dadaa90af4c2BENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1021-2BENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025%30 g in 1 BOTTLE, PUMPGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1021BENZOYL PEROXIDE 5% / NIACINAMIDE 2% / TRETINOIN 0.025% GEL [SINCERUS, FLORIDA, LLC]2Legacy NDC, 1 package rows20200604_87ee6153-34bd-164d-e053-2a95a90a91e1.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
72934-102172934-1021-2

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
BENZOYL PEROXIDEW9WZN9A0GMACTIB
NIACINAMIDE25X51I8RD4ACTIB
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
a73176b0-b460-3810-e053-2995a90a97be87ee6153-34bd-164d-e053-2a95a90a91e12020-06-03Adverse reactionsExact identifier
spl id: a73176b0-b460-3810-e053-2995a90a97be
spl set id: 87ee6153-34bd-164d-e053-2a95a90a91e1

Reported adverse events (FAERS/openFDA)#

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