CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%

Manufacturer: Sincerus Florida, LLC
Effective date: 2019-05-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:28:53

Label at a glance#

ProductCICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%

Active ingredientCICLOPIROX OLAMINE, ITRACONAZOLE, UREA

Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

sdf

Active, inactive

COMPONENTS

NDC 72934- 2044-2 CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%. Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CICLOPIROX Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
ITRACONAZOLE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20190118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d9fdd44-2f2e-2968-36a7-2e5aa5ad971e	Product name	4	20210511
177ecfe5-1d67-dab4-615e-cac2b457a3c1	Product name	8	20191002
9d180e3e-4d31-448b-8857-92c67ed2461a	Product name	1	20190410
d24c6245-86b5-4444-bc75-c1ac73ab3016	Product name	1	20180612
c7015f08-288e-4cfa-93b5-f4959a4814ae	Product name	1	20150324
3f974526-143f-9d19-ee0c-98eeee0cdc3f	Product name	1	20140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86	Product name	1	20140508
7ac2304e-2df8-d230-3b61-1cd07aab1554	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72934-2044-2	2021-01-29	C162847	48780-1	ba0f9c33-4467-a910-e053-dadaa90a0b85	CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72934-2044-2	CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%	30 g in 1 BOTTLE, PUMP	CREAM	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72934-2044	CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20% CREAM [SINCERUS FLORIDA, LLC]	1	Legacy NDC, 1 package rows	20190521_8956c20e-0268-317e-e053-2a95a90a486f.zip

Products#

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

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

CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%
CICLOPIROX OLAMINE
CICLOPIROX
ITRACONAZOLE
UREA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72934-2044	72934-2044-2

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
Name	UNII	Kind
CICLOPIROX OLAMINE	50MD4SB4AP	ACTIM
ITRACONAZOLE	304NUG5GF4	ACTIB
UREA	8W8T17847W	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8956c20e-0269-317e-e053-2a95a90a486f			8956c20e-0268-317e-e053-2a95a90a486f	2019-05-20	Adverse reactions	Exact identifier spl id: 8956c20e-0269-317e-e053-2a95a90a486f spl set id: 8956c20e-0268-317e-e053-2a95a90a486f

Reported adverse events (FAERS/openFDA)#

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