warnings
WARNINGS Ciclopirox gel is not for ophthalmic, oral, or intravaginal use. Keep out of reach of children.
ciclopirox
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
- ciclopirox
- Generic name
- CICLOPIROX
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3c22416e-4293-4ba5-a983-137cbc6022db
- SPL ID
- 941ab9d0-0c94-48f9-a8d2-8f164b050a6c
- Version
- 6
- Effective date
- 2026-01-23
- 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 01:47:20
| 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 | 091595 | derived:openfda.application_number |
| application number | ANDA091595 | openfda.application_number | |
| brand name | ciclopirox | openfda.brand_name | |
| generic name | CICLOPIROX | openfda.generic_name | |
| manufacturer name | Glenmark Pharmaceuticals Inc., USA | openfda.manufacturer_name | |
| ndc | package | 68462-455-47 | openfda.package_ndc |
| ndc | package | 68462-455-94 | openfda.package_ndc |
| ndc | package | 68462-455-35 | openfda.package_ndc |
| ndc | product | 68462-455 | openfda.product_ndc |
| ndc11 | package | 68462045535 | derived:openfda.package_ndc |
| ndc11 | package | 68462045547 | derived:openfda.package_ndc |
| ndc11 | package | 68462045594 | derived:openfda.package_ndc |
| rxcui | 313941 | openfda.rxcui | |
| spl id | 941ab9d0-0c94-48f9-a8d2-8f164b050a6c | id | |
| spl set id | 3c22416e-4293-4ba5-a983-137cbc6022db | set_id | |
| unii | 19W019ZDRJ | 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 clinical trials, 140 (39%) of 359 subjects treated with ciclopirox gel reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.