warnings
WARNINGS Ciclopirox Gel, 0.77% 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
- Padagis US LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- b6a02568-867b-4c7b-890f-5d28bf0b363d
- SPL ID
- 04609ea1-41be-4aa6-ad71-7424db6ae548
- Version
- 7
- Effective date
- 2024-11-01
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:19:13
| 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 | 078266 | derived:openfda.application_number |
| application number | ANDA078266 | openfda.application_number | |
| brand name | CICLOPIROX | openfda.brand_name | |
| generic name | CICLOPIROX | openfda.generic_name | |
| manufacturer name | Padagis US LLC | openfda.manufacturer_name | |
| ndc | package | 0574-2061-30 | openfda.package_ndc |
| ndc | package | 0574-2061-01 | openfda.package_ndc |
| ndc | package | 0574-2061-45 | openfda.package_ndc |
| ndc | product | 0574-2061 | openfda.product_ndc |
| ndc11 | package | 00574206130 | derived:openfda.package_ndc |
| ndc11 | package | 00574206145 | derived:openfda.package_ndc |
| ndc11 | package | 00574206101 | derived:openfda.package_ndc |
| rxcui | 313941 | openfda.rxcui | |
| spl id | 04609ea1-41be-4aa6-ad71-7424db6ae548 | id | |
| spl set id | b6a02568-867b-4c7b-890f-5d28bf0b363d | 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, 0.77% 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.