FDA.reportPublic FDA data

KETOCONAZOLE 2% / SALICYLIC ACID 2%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:47

Label at a glance#

ProductKETOCONAZOLE 2% / SALICYLIC ACID 2%
Active ingredientSALICYLIC ACID, KETOCONAZOLE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

ssss

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

cscs

Active, inactive

COMPONENTS

sdsd

NDC 72934- 7133-6 KETOCONAZOLE USP 2% / SALICYLIC ACID USP 2%. Shampoo 120gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SFSF

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-7133-62021-01-29C16284748780-1ba0f9c33-26e0-a910-e053-dadaa90a0b85KETOCONAZOLE 2% / SALICYLIC ACID 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-7133-6KETOCONAZOLE 2% / SALICYLIC ACID 2%120 g in 1 CYLINDERSHAMPOO1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-7133KETOCONAZOLE 2% / SALICYLIC ACID 2% SHAMPOO [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190517_89062fdd-eed2-022a-e053-2995a90a53da.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-713372934-7133-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
KETOCONAZOLER9400W927IACTIB

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
89062fdd-eed3-022a-e053-2995a90a53da89062fdd-eed2-022a-e053-2995a90a53da2019-05-16Adverse reactionsExact identifier
spl id: 89062fdd-eed3-022a-e053-2995a90a53da
spl set id: 89062fdd-eed2-022a-e053-2995a90a53da

Reported adverse events (FAERS/openFDA)#

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