FDA label 36aff2ea-395c-9326-e063-6294a90aef21
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
- SPL set ID
- 1a1be0fb-c238-4990-bd48-03096bbf6052
- SPL ID
- 36aff2ea-395c-9326-e063-6294a90aef21
- Version
- 12
- Effective date
- 2025-06-03
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:29:34
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 36aff2ea-395c-9326-e063-6294a90aef21 | id | |
| spl set id | 1a1be0fb-c238-4990-bd48-03096bbf6052 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Keep out of reach of children.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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, and miliaria. In controlled clinical studies the incidence of adverse reactions were low (0.8%) for Topicort ® (desoximetasone cream USP) 0.25%, and included burning, folliculitis, and folliculo-pustular lesions. The incidence of adverse reactions were also 0.8% for Topicort ® (desoximetasone cream USP) 0.05% and included pruritus, erythema, vesiculation, and burning sensation. The incidence of adverse reactions for Topicort ® (desoximetasone gel USP), 0.05% was 0.3% with one subject reporting stinging and burning at the site of application.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.