FDA.reportPublic FDA data

CALCIPOTRIENE 0.005% / CLOBETASOL PROPIONATE 0.05%

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#

ProductCALCIPOTRIENE 0.005% / CLOBETASOL PROPIONATE 0.05%
Active ingredientCALCIPOTRIENE, CLOBETASOL PROPIONATE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

sdsd

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

fsffsf

Active, inactive

COMPONENTS

cscs

NDC 72934- 4029-5 CALCIPOTRIENE USP 0.005% / CLOBETASOL PROPIONATE USP 0.05%. Solution 60 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sdsd

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIPOTRIENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CLOBETASOL Pharmacologic Class Indexing2Indexing - 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
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-4029-52021-01-29C16284748780-1ba0f9c33-447c-a910-e053-dadaa90a0b85CALCIPOTRIENE 0.005% / CLOBETASOL PROPIONATE 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-4029-5CALCIPOTRIENE 0.005% / CLOBETASOL PROPIONATE 0.05%60 g in 1 CYLINDERSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-4029CALCIPOTRIENE 0.005% / CLOBETASOL PROPIONATE 0.05% SOLUTION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190521_8957fab8-eca0-2494-e053-2995a90a6c29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-4029-3GM - Gram72934-4029ffbd0cce-c14e-4af9-a92d-9a11513d2bdd12020-03-10

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
72934-402972934-4029-5

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
CALCIPOTRIENE143NQ3779BACTIB
CLOBETASOL PROPIONATE779619577MACTIB

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
8957fab8-eca1-2494-e053-2995a90a6c298957fab8-eca0-2494-e053-2995a90a6c292019-05-20Adverse reactionsExact identifier
spl id: 8957fab8-eca1-2494-e053-2995a90a6c29
spl set id: 8957fab8-eca0-2494-e053-2995a90a6c29

Reported adverse events (FAERS/openFDA)#

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