Home FDA labels 531184f7-770c-46a4-9bfa-3dbf2a575aa6 FDA label 531184f7-770c-46a4-9bfa-3dbf2a575aa6 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 2aa35781-40e0-7ce9-45fa-f97333f29085
SPL ID 531184f7-770c-46a4-9bfa-3dbf2a575aa6
Version 3
Effective date 2018-06-20
Source export date 2026-09-28
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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adverse reactions ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform Eruptions Hypopigmentation Perioral Dermatitis Allergic Contact Dermatitis Maceration of the Skin Secondary Infection Skin Atrophy Striae Miliaria To report SUSPECTED ADVERSE REACTIONS contact Teligent Pharma, Inc. at 856-697-1441 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table width="85%"> <col align="left" valign="top" width="25%"/> <col align="left" valign="top" width="40%"/> <col align="left" valign="top" width="35%"/> <tbody> <tr styleCode="Toprule Botrule"> <td> <list listType="unordered"> <item> <caption> </caption>Burning</item> <item> <caption> </caption>Itching</item> <item> <caption> </caption>Irritation</item> <item> <caption> </caption>Dryness</item> <item> <caption> </caption>Folliculitis</item> </list> </td> <td> <list listType="unordered"> <item> <caption> </caption>Hypertrichosis</item> <item> <caption> </caption>Acneiform Eruptions</item> <item> <caption> </caption>Hypopigmentation</item> <item> <caption> </caption>Perioral Dermatitis</item> <item> <caption> </caption>Allergic Contact Dermatitis</item> </list> </td> <td> <list listType="unordered"> <item> <caption> </caption>Maceration of the Skin</item> <item> <caption> </caption>Secondary Infection</item> <item> <caption> </caption>Skin Atrophy</item> <item> <caption> </caption>Striae</item> <item> <caption> </caption>Miliaria</item> </list> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.