Clobetasol Propionate ANDA

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
Clobetasol Propionate ANDA
Generic name
CLOBETASOL PROPIONATE
Manufacturer
Macleods Pharmaceuticals Limited
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
92cf4231-e301-4353-98d9-85206ec6ba96
SPL ID
92cf4231-e301-4353-98d9-85206ec6ba96
Version
1
Effective date
2024-01-05
Source export date
2026-10-27
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 21:08:02
Harmonized routes table
Harmonized routes
TOPICAL

Adverse reactions cross-check#

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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 clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing's 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 have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, 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.