Home FDA labels db86f8ff-6977-7ce2-e053-2995a90ae128 FDA label db86f8ff-6977-7ce2-e053-2995a90ae128 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID db86f8bd-1537-f6dd-e053-2a95a90a672e
SPL ID db86f8ff-6977-7ce2-e053-2995a90ae128
Version 1
Effective date 2022-03-31
Source export date 2026-08-08
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-08/e78f1fb32bf83ef6e9a19dc8cb100566f7817d0ac9ed04e609562ab8ed7ab1de/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run 20260810T161303Z
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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>