FDA label 184bc39c-1875-4103-9d3f-2ab7b348db2e

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
892bf494-0b95-4314-a253-79350fdd7238
SPL ID
184bc39c-1875-4103-9d3f-2ab7b348db2e
Version
5
Effective date
2019-09-16
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:18

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 total incidence of adverse events associated with the use of betamethasone dipropionate gel (augmented) was 10%. These included stinging or burning in 6% of patients, dry skin in 4% of patients, and pruritus in 2% of patients. Less frequently reported adverse reactions were irritation, skin atro- phy, telangiectasia, erythema, cracking/tightening of the skin, follicular rash, and allergic contact dermatitis. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids, such as betamethasone dipropionate gel (augmented). These reactions are listed in approximate decreasing order of occurrence: acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.

Reported adverse events (FAERS/openFDA)#

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