FDA.reportPublic FDA data

NIACINAMIDE 4% / TRETINOIN 0.1% GEL

Manufacturer
Sincerus Florida, LLC
Effective date
2019-03-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:23

Label at a glance#

ProductNIACINAMIDE 4% / TRETINOIN 0.1%
Active ingredientTRETINOIN, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

Directions for use As directed by physician. Apply topically. For external use only. Wash hands after use. Store at controlled room temperature 20-25 CelsiusDirections for use As directed by physician. Apply topically. For external use only. Wash hands after use. Store at controlled room temperature 20-25 Celsius

Sincerus Florida, LLC; Adverse reactions

ADVERSE REACTIONS SECTION

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Active;Inactive

COMPONENTS

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NDC 72934-1165-2 NIACINAMIDE 4% / TRETINOIN 0.1% GEL 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel 30gm Sincerus Florida This is a compounded drug Made in USAGel 30gm Sincerus Florida This is a compounded drug Made in USA

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
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
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
72934-1165-22021-01-29C16284748780-1ba0f9c33-4ec2-a910-e053-dadaa90a0b85NIACINAMIDE 4% / TRETINOIN 0.1% GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1165-2NIACINAMIDE 4% / TRETINOIN 0.1%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1165NIACINAMIDE 4% / TRETINOIN 0.1% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_852c07b2-5274-28b0-e053-2a91aa0a4e70.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-116572934-1165-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRETINOIN5688UTC01RACTIB
NIACINAMIDE25X51I8RD4ACTIB

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
852c07b2-5275-28b0-e053-2a91aa0a4e70852c07b2-5274-28b0-e053-2a91aa0a4e702019-03-29Adverse reactionsExact identifier
spl id: 852c07b2-5275-28b0-e053-2a91aa0a4e70
spl set id: 852c07b2-5274-28b0-e053-2a91aa0a4e70

Reported adverse events (FAERS/openFDA)#

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