FDA label db3e8338-91c3-4d92-abe5-509c4545aff8

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
ecc6049d-2c2a-40e0-8780-158b166af406
SPL ID
db3e8338-91c3-4d92-abe5-509c4545aff8
Version
2
Effective date
2012-04-15
Source export date
2026-11-06
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/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:31:48

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS In a controlled trial with TEMOVATE ® Gel, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy, and telangiectasia (all less than 2%). Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions are reported infrequently with topical corti-costeroids, but may occur more frequently with super-high potency corticosteroids such as TEMOVATE ® Gel. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Reported adverse events (FAERS/openFDA)#

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