warnings
WARNINGS Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Drug product is flammable. Keep away from open flame.
Pellix
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
- Pellix
- Generic name
- CALCIPOTRIENE
- Manufacturer
- Perfero Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 492ea9cf-0117-4d84-a964-9c0121706ed3
- SPL ID
- ba4b6a09-9cc9-4617-8c81-b09ecca5fb9e
- Version
- 2
- Effective date
- 2026-05-04
- Source export date
- 2026-10-12
- 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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:46:03
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| application applno | ANDA | 078468 | derived:openfda.application_number |
| application number | ANDA078468 | openfda.application_number | |
| brand name | Pellix | openfda.brand_name | |
| generic name | CALCIPOTRIENE | openfda.generic_name | |
| manufacturer name | Perfero Pharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 87143-300-60 | openfda.package_ndc |
| ndc | product | 87143-300 | openfda.product_ndc |
| ndc11 | package | 87143030060 | derived:openfda.package_ndc |
| rxcui | 308865 | openfda.rxcui | |
| rxcui | 2742555 | openfda.rxcui | |
| spl id | ba4b6a09-9cc9-4617-8c81-b09ecca5fb9e | id | |
| spl set id | 492ea9cf-0117-4d84-a964-9c0121706ed3 | set_id | |
| unii | 143NQ3779B | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported to be related to Pellix™ Topical Solution, 0.005% (Scalp Solution), use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients, Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded. To report SUSPECTED ADVERSE REACTIONS, contact Perfero Pharma, Inc. at 1-973-629-0109 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.