Home FDA labels 64167760-d963-439f-ac85-21eefb5e8b39 Fluocinonide Cream 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)
Brand name Fluocinonide Cream
Generic name FLUOCINONIDE
Manufacturer Amneal Pharmaceuticals NY LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 817cac6b-fec5-406d-aa0c-8852d08a3c65
SPL ID 64167760-d963-439f-ac85-21eefb5e8b39
Version 8
Effective date 2023-06-06
Source export date 2026-11-06
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/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 07:01:13 Harmonized routes table Harmonized routes TOPICAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 18 matching rows.
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 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 cellspacing="0" cellpadding="0" border="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.