warnings
WARNINGS FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes.
Calyxra
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
- Brand name
- Calyxra
- Generic name
- CALCIPOTRIENE CREAM, 0.005%
- Manufacturer
- Florrax Pharmaceutical
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b18f6071-7be6-4ae0-b4a0-22353fc4263e
- SPL ID
- 06be3d58-249c-49e1-9756-d19880bd606c
- Version
- 2
- Effective date
- 2026-03-24
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:14
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 |
|---|---|---|---|
| brand name | Calyxra | openfda.brand_name | |
| generic name | CALCIPOTRIENE CREAM, 0.005% | openfda.generic_name | |
| manufacturer name | Florrax Pharmaceutical | openfda.manufacturer_name | |
| ndc | package | 68462-501-65 | openfda.package_ndc |
| ndc | package | 84460-803-01 | openfda.package_ndc |
| ndc | product | 84460-803 | openfda.product_ndc |
| ndc11 | package | 68462050165 | derived:openfda.package_ndc |
| ndc11 | package | 84460080301 | derived:openfda.package_ndc |
| rxcui | 313921 | openfda.rxcui | |
| spl id | 06be3d58-249c-49e1-9756-d19880bd606c | id | |
| spl set id | b18f6071-7be6-4ae0-b4a0-22353fc4263e | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.