FDA.reportPublic FDA data

CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05%

Manufacturer
Sincerus Florida, LLC
Effective date
2020-06-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:52

Key Label Information#

Directions And Dosage

Directions for use

Other Label Information

NDC 72934-2054-2. CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05%. Cream 30gm.

Label Images#

-2 end
-2 end
2054-2 Ingredients (2)
2054-2 Ingredients (2)
2054-2 front
2054-2 front

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ALITRETINOIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CLINDAMYCIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20210811

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
4bcb0bb4-29a4-19be-727f-280b88bbde80Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2054-22022-01-28C16284748780-1d6a99b39-5a15-a426-e053-dadaa90af4c2CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2054-2CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05%30 g in 1 BOTTLE, PUMPCREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2054CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05% CREAM [SINCERUS FLORIDA, LLC]2Legacy NDC, 1 package rows20200605_87fde97e-ac4e-e3da-e053-2a95a90a9b19.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-205472934-2054-2

Ingredients#

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4ACTIB
CLINDAMYCIN PHOSPHATEEH6D7113I8ACTIB
ALITRETINOIN1UA8E65KDZACTIB

Complete SPL Sections#

Directions for use

INSTRUCTIONS FOR USE SECTION

Sincerus Florida, LLC adverse reactions

ADVERSE REACTIONS SECTION

Active, inactive

COMPONENTS

NDC 72934-2054-2. CLINDAMYCIN 1% / NIACINAMIDE 4% / TRETINOIN 0.05%. Cream 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML ยท Source PDF