warnings
WARNINGS General - Ciclopirox Olamine Topical Suspension USP, 1.0% is not for ophthalmic use. Keep out of reach of children.
Ciclopirox Olamine
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 Olamine
- Generic name
- CICLOPIROX OLAMINE
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- eadbd29d-5990-4987-833f-40cd0b2d2868
- SPL ID
- 372d6df9-d395-4ee2-9d16-9f21399f8604
- Version
- 10
- Effective date
- 2026-04-16
- Source export date
- 2026-09-28
- 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/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:41:27
| 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 | 077676 | derived:openfda.application_number |
| application number | ANDA077676 | openfda.application_number | |
| brand name | Ciclopirox Olamine | openfda.brand_name | |
| generic name | CICLOPIROX OLAMINE | openfda.generic_name | |
| manufacturer name | Padagis Israel Pharmaceuticals Ltd | openfda.manufacturer_name | |
| ndc | package | 45802-400-46 | openfda.package_ndc |
| ndc | package | 45802-400-49 | openfda.package_ndc |
| ndc | product | 45802-400 | openfda.product_ndc |
| ndc11 | package | 45802040046 | derived:openfda.package_ndc |
| ndc11 | package | 45802040049 | derived:openfda.package_ndc |
| rxcui | 309290 | openfda.rxcui | |
| spl id | 372d6df9-d395-4ee2-9d16-9f21399f8604 | id | |
| spl set id | eadbd29d-5990-4987-833f-40cd0b2d2868 | set_id | |
| unii | 50MD4SB4AP | 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 the controlled clinical trial with 89 patients using ciclopirox olamine topical suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox olamine topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox olamine topical suspension. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 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.