Home FDA labels 266c3c51-3913-4823-812b-7704a2caa570 Fluocinolone Acetonide Topical Solution USP, 0.01% 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 Fluocinolone Acetonide Topical Solution USP, 0.01%
Generic name FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
Manufacturer Bryant Ranch Prepack
Product type HUMAN PRESCRIPTION DRUG
SPL set ID ce89966d-d7ea-4986-936e-6d46aee497cd
SPL ID 266c3c51-3913-4823-812b-7704a2caa570
Version 104
Effective date 2024-08-20
Source export date 2026-10-22
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-22/1efc345682dd2c7d09122ceeaeceedc25aaee91e2e580bbcb238c97f7d29f85b/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run 20261023T001338Z
Imported at 2026-10-23 01:11:13 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 · 12 matching rows.
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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 Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="526.68"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Burning </td><td styleCode="Rrule" valign="top">Perioral dermatitis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Itching </td><td styleCode="Rrule" valign="top">Allergic contact dermatitis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Irritation </td><td styleCode="Rrule" valign="top">Maceration of the skin </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Dryness </td><td styleCode="Rrule" valign="top">Secondary infection </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Folliculitis </td><td styleCode="Rrule" valign="top">Skin atrophy </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Hypertrichosis </td><td styleCode="Rrule" valign="top">Striae </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">Acneiform eruptions </td><td styleCode="Rrule" valign="top">Miliaria </td></tr><tr><td styleCode="Lrule Rrule" valign="top">Hypopigmentation </td><td styleCode="Rrule" valign="top"> </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.