FDA label cfb7782a-0363-4ea1-a7cc-259afa5336d1

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
c77f3c7e-e8ef-4169-9672-04599a63638a
SPL ID
cfb7782a-0363-4ea1-a7cc-259afa5336d1
Version
3
Effective date
2012-01-03
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:39

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.05% (augmented) during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.05% (augmented) during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months - 12 years of age. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Reported adverse events (FAERS/openFDA)#

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