FDA.reportPublic FDA data

ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%

Manufacturer
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#

ProductADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%
Active ingredientCLINDAMYCIN PHOSPHATE, ADAPALENE, BENZOYL PEROXIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dd

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

xx

Active and Inactive

COMPONENTS

123123

NDC 72934-1002-2 ADAPALENE USP 0.1% / BENZOYL PEROXIDE USP 2.5% / CLINDAMYCIN USP 1%. Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ss

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADAPALENE 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
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1002-22022-01-28C16284748780-1d6a99b39-59a0-a426-e053-dadaa90af4c2ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1002-2ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%30 g in 1 BOTTLE, PUMPGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1002ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1% GEL [SINCERUS FLORIDA, LLC]2Legacy NDC, 1 package rows20200604_887ae1db-bcb4-2e8b-e053-2a95a90abc08.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-100272934-1002-2

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
CLINDAMYCIN PHOSPHATEEH6D7113I8ACTIB
ADAPALENE1L4806J2QFACTIB
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
a7306f8c-3d3d-54b4-e053-2a95a90ae196887ae1db-bcb4-2e8b-e053-2a95a90abc082020-06-03Adverse reactionsExact identifier
spl id: a7306f8c-3d3d-54b4-e053-2a95a90ae196
spl set id: 887ae1db-bcb4-2e8b-e053-2a95a90abc08

Reported adverse events (FAERS/openFDA)#

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