Home FDA labels e5bf0ef1-02a9-0b9d-e053-2995a90a763f FDA label e5bf0ef1-02a9-0b9d-e053-2995a90a763f 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 e5bf009d-b80b-60f3-e053-2995a90a6d66
SPL ID e5bf0ef1-02a9-0b9d-e053-2995a90a763f
Version 1
Effective date 2022-08-08
Source export date 2026-09-28
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:24:42 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
adverse reactions table <table border="0" cellspacing="0" cellpadding="0"><col width="2.55in"/><col width="2.55in"/><col width="2.55in"/><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule "><paragraph>Burning</paragraph><paragraph>Itching</paragraph><paragraph>Irritation</paragraph><paragraph>Dryness</paragraph><paragraph>Folliculitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule "><paragraph>Hypertrichosis</paragraph><paragraph>Acneiform Eruptions</paragraph><paragraph>Hypopigmentation</paragraph><paragraph>Perioral Dermatitis</paragraph><paragraph>Allergic Contact Dermatitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule "><paragraph>Maceration of the Skin</paragraph><paragraph>Secondary Infection</paragraph><paragraph>Skin Atrophy</paragraph><paragraph>Striae</paragraph><paragraph>Miliaria</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.