FDA.reportPublic FDA data

NIACINAMIDE 4% / TRETINOIN 0.05%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:34

Key Label Information#

Directions And Dosage

Directions for use

Other Label Information

NDC 72934-1164-2 NIACINAMIDE USP 4% / TRETINOIN USP 0.05%. Gel 30gm

Label Images#

1164 end
1164 end
1164 middle
1164 middle
1164 front
1164 front

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
72934-1164-22021-01-29C16284748780-1ba0f9c33-4f6d-a910-e053-dadaa90a0b85NIACINAMIDE 4% / TRETINOIN 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1164-2NIACINAMIDE 4% / TRETINOIN 0.05%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1164NIACINAMIDE 4% / TRETINOIN 0.05% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190504_87fde6db-944d-e50d-e053-2a95a90a52a4.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-116472934-1164-2

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TRETINOIN5688UTC01RACTIB
NIACINAMIDE25X51I8RD4ACTIB

Complete SPL Sections#

Directions for use

INSTRUCTIONS FOR USE SECTION

Sincerus Florida, adverse reactions

ADVERSE REACTIONS SECTION

Active, inactives

COMPONENTS

NDC 72934-1164-2 NIACINAMIDE USP 4% / TRETINOIN USP 0.05%. Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML