FDA.reportPublic FDA data

FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%

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#

ProductFLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%
Active ingredientIBUPROFEN, ITRACONAZOLE, TERBINAFINE, FLUCONAZOLE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ee

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

qq

NDC 72934-4176-9 FLUCONAZOLE USP 4% / IBUPROFEN USP 2% / ITRACONAZOLE USP 1% / TERBINAFINE HCL USP 4%. Solution 15gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
ITRACONAZOLE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20190118
TERBINAFINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
9d9fdd44-2f2e-2968-36a7-2e5aa5ad971eProduct name420210511
177ecfe5-1d67-dab4-615e-cac2b457a3c1Product name820191002
9d180e3e-4d31-448b-8857-92c67ed2461aProduct name120190410
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7ac2304e-2df8-d230-3b61-1cd07aab1554Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct 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
72934-4176-92021-01-29C16284748780-1ba0f9c33-449d-a910-e053-dadaa90a0b85FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4176-9FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%15 g in 1 VIAL, GLASSSOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4176FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_87480522-a42c-5023-e053-2995a90afd30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-4176-9GM - Gram72934-4176e6135fb4-e4b2-4cd3-be82-fc59e5e51e3312020-03-10

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
72934-417672934-4176-9

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
IBUPROFENWK2XYI10QMACTIB
ITRACONAZOLE304NUG5GF4ACTIB
TERBINAFINEG7RIW8S0XPACTIB
FLUCONAZOLE8VZV102JFYACTIB

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
87480522-a42d-5023-e053-2995a90afd3087480522-a42c-5023-e053-2995a90afd302019-04-24Adverse reactionsExact identifier
spl id: 87480522-a42d-5023-e053-2995a90afd30
spl set id: 87480522-a42c-5023-e053-2995a90afd30

Reported adverse events (FAERS/openFDA)#

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