FDA label 53e17bda-5532-4bb9-b2a3-1c6c50e2f7f4

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
27d39f64-ee15-4beb-bbd0-31f8c42ca5e0
SPL ID
53e17bda-5532-4bb9-b2a3-1c6c50e2f7f4
Version
5
Effective date
2015-04-27
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:08

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 2 matching rows.

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 Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

adverse reactions table

<table width="60%"><col align="left" valign="top" width="50%"/><col align="right" valign="top" width="50%"/><tbody><tr><td>Burning</td><td>Perioral dermatitis</td></tr><tr><td>Itching</td><td>Allergic contact dermatitis</td></tr><tr><td>Irritation</td><td>Maceration of the skin</td></tr><tr><td>Dryness</td><td>Secondary infection</td></tr><tr><td>Folliculitis </td><td>Skin atrophy</td></tr><tr><td>Hypertrichosis</td><td>Striae</td></tr><tr><td>Acneiform eruptions</td><td>Miliaria</td></tr><tr><td>Hypopigmentation</td><td/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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