Home FDA labels a576ca07-a02d-164d-e053-2995a90a50dc FDA label a576ca07-a02d-164d-e053-2995a90a50dc 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 272d9245-20bc-996e-c562-8116c2d911ba
SPL ID a576ca07-a02d-164d-e053-2995a90a50dc
Version 6
Effective date 2020-05-12
Source export date 2026-09-28
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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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 malaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide oil 0.01%. A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide 0.01% tropical oil 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 * 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 Treatment *** Four Weeks Post Treatment Adverse Event (AE) * # of patients (%) Day 14 Day 28 ** Day 56 *** 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)
adverse reactions table <table frame="void" width="628"> <caption> Incidence of Adverse Events (%)N=58</caption> <tfoot> <tr> <td align="left" colspan="5" styleCode="Toprule" valign="top"> <content styleCode="bold"> <sup>*</sup> </content> <content styleCode="bold">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.</content> <content styleCode="bold"> </content> <content styleCode="bold"> <sup>**</sup> </content> <content styleCode="bold">End of Treatment</content> <content styleCode="bold"> </content> <content styleCode="bold"> <sup>***</sup> </content> <content styleCode="bold">Four Weeks Post Treatment</content> </td> </tr> </tfoot> <tbody> <tr> <td align="center" styleCode="BotruleLruleRruleToprule" valign="top">Adverse Event (AE) <sup>*</sup> </td> <td align="center" styleCode="BotruleLruleRruleToprule" valign="top"># of patients (%)</td> <td align="center" styleCode="BotruleLruleRruleToprule" valign="top">Day 14</td> <td align="center" styleCode="BotruleLruleRruleToprule" valign="top">Day 28 <sup>**</sup> </td> <td align="center" styleCode="BotruleLruleRruleToprule" valign="top">Day 56 <sup>***</sup> </td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Any AE</td> <td styleCode="BotruleLruleRruleToprule" valign="top">15 (25.9)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">6 (10.3)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">7 (12.1)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">7 (12.1)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Telangiectasia</td> <td styleCode="BotruleLruleRruleToprule" valign="top">5 (8.6)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">4 (6.9)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">2 (3.5)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Erythema</td> <td styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Itching</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Irritation</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Burning</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">3 (5.2)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Hypopigmentation</td> <td styleCode="BotruleLruleRruleToprule" valign="top">2 (3.5)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">2 (3.5)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Shiny skin</td> <td styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Secondary atopic dermatitis</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Papules and pustules</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Keratosis pilaris</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Folliculitis</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Facial herpes simplex</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Acneiform eruption</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> <tr> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">Ear infection</td> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> <td align="left" styleCode="BotruleLruleRruleToprule" valign="top">1 (1.7)</td> <td styleCode="BotruleLruleRruleToprule" valign="top"/> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.