FDA.reportPublic FDA data

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:27

Label at a glance#

ProductCICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%
Active ingredientCICLOPIROX, FLUCONAZOLE, TERBINAFINE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ss

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

dd

Active, inactive

COMPONENTS

aa

NDC 72934-4045-9 CICLOPIROX OLAMINE USP 8% / FLUCONAZOLE USP 1% / TERBINAFINE HCL USP 1%. Solution 15gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ss

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CICLOPIROX Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FLUCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
TERBINAFINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-4045-92021-01-29C16284748780-1ba0f9c33-3add-a910-e053-dadaa90a0b85CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4045-9CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%15 g in 1 VIAL, GLASSSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4045CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_87480bb9-e7a7-5ef1-e053-2995a90a0e40.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-404572934-4045-9

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
CICLOPIROX19W019ZDRJACTIB
FLUCONAZOLE8VZV102JFYACTIB
TERBINAFINEG7RIW8S0XPACTIB

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
87480bb9-e7a8-5ef1-e053-2995a90a0e4087480bb9-e7a7-5ef1-e053-2995a90a0e402019-04-24Adverse reactionsExact identifier
spl id: 87480bb9-e7a8-5ef1-e053-2995a90a0e40
spl set id: 87480bb9-e7a7-5ef1-e053-2995a90a0e40

Reported adverse events (FAERS/openFDA)#

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