warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
FDA label d0707037-c9cd-4c52-a1f5-4c8f72f62010
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
- SPL set ID
- 7ec750f6-26ea-46bc-aa7b-174fd25253a2
- SPL ID
- d0707037-c9cd-4c52-a1f5-4c8f72f62010
- Version
- 7
- Effective date
- 2025-10-27
- Source export date
- 2026-10-12
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:13:59
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | d0707037-c9cd-4c52-a1f5-4c8f72f62010 | id | |
| spl set id | 7ec750f6-26ea-46bc-aa7b-174fd25253a2 | set_id |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS Clinical Trials Experience In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis. To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.