FDA label 45b5b9ea-25e2-648e-e054-00144ff88e88

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
e4cb9989-da6e-4e82-ba4e-e97f4f246ecc
SPL ID
45b5b9ea-25e2-648e-e054-00144ff88e88
Version
2
Effective date
2017-01-09
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:32:00

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 1 . 9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients. The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), and sensitization (local reactions upon repeated application of product). In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate cream include growth retardation, benign intracranial hypertension, Cushing’s syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy. 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. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.

Reported adverse events (FAERS/openFDA)#

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