FDA.reportPublic FDA data

CLOBETASOL PROPIONATE 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE 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#

ProductCLOBETASOL PROPIONATE 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%
Active ingredientCLOBETASOL PROPIONATE, LEVOCETIRIZINE DIHYDROCHLORIDE
Label structure4 sections

Label contents#

Full prescribing information#

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Directions for use

INSTRUCTIONS FOR USE SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 7058-6 CLOBETASOL PROPIONATE USP 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE USP 2% . Shampoo 120 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOBETASOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-7058-62021-01-29C16284748780-1ba0f9c33-44fa-a910-e053-dadaa90a0b85CLOBETASOL PROPIONATE 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-7058-6CLOBETASOL PROPIONATE 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE 2%120 g in 1 BOTTLE, PLASTICSHAMPOO1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-7058CLOBETASOL PROPIONATE 0.05% / LEVOCETIRIZINE DIHYDROCHLORIDE 2% SHAMPOO [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190517_8903ce74-bf78-1c4a-e053-2995a90a69f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-7058-6GM - Gram72934-7058a97cce1f-65d8-4c75-a58c-d4856bc48ec712020-03-10

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
72934-705872934-7058-6

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
CLOBETASOL PROPIONATE779619577MACTIB
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB

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
8903ce74-bf79-1c4a-e053-2995a90a69f28903ce74-bf78-1c4a-e053-2995a90a69f22019-05-16Adverse reactionsExact identifier
spl id: 8903ce74-bf79-1c4a-e053-2995a90a69f2
spl set id: 8903ce74-bf78-1c4a-e053-2995a90a69f2

Reported adverse events (FAERS/openFDA)#

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