FDA label 346cc153-69ac-4e6f-802c-3ba322347598

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)

SPL set ID
b73836e9-7ccc-41bb-b4ef-65ad2d865085
SPL ID
346cc153-69ac-4e6f-802c-3ba322347598
Version
2
Effective date
2012-10-15
Source export date
2026-11-06
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:43:13

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for Ultravate Cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Ultravate Cream. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.