Home FDA labels baea426a-aa38-4e7e-afff-d9e0b3d9f514 Fluocinolone Acetonide 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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Brand name Fluocinolone Acetonide
Generic name FLUOCINOLONE ACETONIDE
Manufacturer Bryant Ranch Prepack
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 30b0013a-d289-4230-8f50-0a0ff05f4b5e
SPL ID baea426a-aa38-4e7e-afff-d9e0b3d9f514
Version 102
Effective date 2026-06-18
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
Imported at 2026-09-29 05:55:43 Harmonized routes table Harmonized routes TOPICAL
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adverse reactions ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events ). Incidence of Adverse Events (%) N=58 Adverse Event (AE) * # of patients (%) Day 14 Day 28 † D ay 56 ‡ * The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. † End of Treat ment ‡ Four Weeks Post Treatment Any AE 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) Telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) Erythema 3 (5.2) 3 (5.2) Itching 3 (5.2) 3 (5.2) Irritation 3 (5.2) 3 (5.2) Burning 3 (5.2) 3 (5.2) Hypopigmentation 2 (3.5) 2 (3.5) Shiny skin 1 (1.7) 1 (1.7) Secondary atopic dermatitis 1 (1.7) 1 (1.7) Papules and pustules 1 (1.7) 1 (1.7) Keratosis pilaris 1 (1.7) 1 (1.7) Folliculitis 1 (1.7) 1 (1.7) Facial herpes simplex 1 (1.7) 1 (1.7) Acneiform eruption 1 (1.7) 1 (1.7) Ear infection 1 (1.7) 1 (1.7) To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table cellspacing="0" cellpadding="0" border="0"><caption>Incidence of Adverse Events (%) N=58 </caption><thead><tr><th styleCode="Lrule Rrule Toprule" colspan="1"><content styleCode="bold">Adverse <content ID="event">Event</content> (AE)<linkHtml href="#number">*</linkHtml></content></th><th styleCode="Lrule Rrule Toprule" colspan="1"><content styleCode="bold"># of patients (%) </content></th><th styleCode="Lrule Rrule Toprule" colspan="1"><content styleCode="bold">Day 14 </content></th><th styleCode="Lrule Rrule Toprule" colspan="1"><content styleCode="bold"><content ID="day">Day</content> 28<linkHtml href="#treat">†</linkHtml></content></th><th styleCode="Lrule Rrule Toprule" colspan="1"><content styleCode="bold"> D<content ID="ay">ay</content> 56<linkHtml href="#weeks">‡</linkHtml></content></th></tr></thead><tfoot><tr><td colspan="5"><content styleCode="bold"><linkHtml href="#event">*</linkHtml> The <content ID="number">number</content> of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. <linkHtml href="#day">†</linkHtml> End of <content ID="treat">Treat</content>ment <linkHtml href="#ay">‡</linkHtml> Four <content ID="weeks">Weeks</content> Post Treatment</content></td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Any AE</td><td styleCode="Rrule" valign="middle"> 15 (25.9)</td><td styleCode="Rrule" valign="middle"> 6 (10.3)</td><td styleCode="Rrule" valign="middle"> 7 (12.1)</td><td styleCode="Rrule" valign="middle"> 7 (12.1)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Telangiectasia</td><td styleCode="Rrule" valign="middle"> 5 (8.6)</td><td styleCode="Rrule" valign="middle"> 3 (5.2)</td><td styleCode="Rrule" valign="middle"> 4 (6.9)</td><td styleCode="Rrule" valign="middle"> 2 (3.5)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Erythema</td><td styleCode="Rrule" valign="middle"> 3 (5.2)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 3 (5.2)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Itching </td><td styleCode="Rrule" valign="middle"> 3 (5.2)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 3 (5.2)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Irritation</td><td styleCode="Rrule" valign="middle"> 3 (5.2)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 3 (5.2)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Burning</td><td styleCode="Rrule" valign="middle"> 3 (5.2)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 3 (5.2)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Hypopigmentation</td><td styleCode="Rrule" valign="middle"> 2 (3.5)</td><td styleCode="Rrule" valign="middle"> 2 (3.5)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Shiny skin</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Secondary atopic dermatitis</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Papules and pustules</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Keratosis pilaris</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Folliculitis</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Facial herpes simplex</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> Acneiform eruption</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/></tr><tr><td styleCode="Lrule Rrule" valign="middle"> Ear infection</td><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/><td styleCode="Rrule" valign="middle"> 1 (1.7)</td><td styleCode="Rrule" valign="middle"/></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.