FDA label 060357b8-8678-4d16-a184-1c85f6c18eaa

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
3190cdcf-e0c4-4563-9d1d-1be0c8803666
SPL ID
060357b8-8678-4d16-a184-1c85f6c18eaa
Version
4
Effective date
2022-06-01
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:55:53

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when Betamethasone Dipropionate Lotion, USP 0.05% w/w is used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria. Adverse reactions reported to be possibly or probably related to treatment with Betamethasone Dipropionate Lotion, USP 0.05% w/w during a pediatric study include: paresthesia (burning), erythema, erythematous rash, and dry skin. These adverse reactions each occurred in a different patient; 4% of the 25 patient population, respectively. An adverse reaction reported to be possibly or probably related to treatment in 2 different patients, 8%, of the 25 patients is puritis. 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.