FDA.reportPublic FDA data

IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:26

Label at a glance#

ProductIMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
Active ingredientTRETINOIN, BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE, NIACINAMIDE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dd

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

vv

Active, inactive

COMPONENTS

ff

NDC 72934-1011-2 BENZOYL PEROXIDE 2.5 / CLINDAMYCIN PHOSPHATE 1/ NIACINAMIDE 2 / TRETINOIN 0.025 gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLINDAMYCIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20210811
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
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
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1011-22021-01-29C16284748780-1ba0f9c33-1cd9-a910-e053-dadaa90a0b85IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1011-2IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1011IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_87390498-2694-6a5c-e053-2991aa0ab647.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-101172934-1011-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRETINOIN5688UTC01RACTIB
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CLINDAMYCIN PHOSPHATEEH6D7113I8ACTIB
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
87390498-2695-6a5c-e053-2991aa0ab64787390498-2694-6a5c-e053-2991aa0ab6472019-04-23Adverse reactionsExact identifier
spl id: 87390498-2695-6a5c-e053-2991aa0ab647
spl set id: 87390498-2694-6a5c-e053-2991aa0ab647

Reported adverse events (FAERS/openFDA)#

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