warnings
WARNINGS Ciclopirox Olamine Cream USP 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
- Cosette Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 5c585aa5-7d2d-e798-c0bd-d602574d643c
- SPL ID
- ed9669ad-fa01-5788-e053-2995a90a5897
- Version
- 9
- Effective date
- 2022-11-16
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:16:03
| 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 | 078463 | derived:openfda.application_number |
| application number | ANDA078463 | openfda.application_number | |
| brand name | Ciclopirox Olamine | openfda.brand_name | |
| generic name | CICLOPIROX OLAMINE | openfda.generic_name | |
| manufacturer name | Cosette Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 0713-0638-15 | openfda.package_ndc |
| ndc | package | 0713-0638-31 | openfda.package_ndc |
| ndc | package | 0713-0638-18 | openfda.package_ndc |
| ndc | product | 0713-0638 | openfda.product_ndc |
| ndc11 | package | 00713063818 | derived:openfda.package_ndc |
| ndc11 | package | 00713063831 | derived:openfda.package_ndc |
| ndc11 | package | 00713063815 | derived:openfda.package_ndc |
| rxcui | 309289 | openfda.rxcui | |
| spl id | ed9669ad-fa01-5788-e053-2995a90a5897 | id | |
| spl set id | 5c585aa5-7d2d-e798-c0bd-d602574d643c | set_id | |
| unii | 50MD4SB4AP | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Olamine Cream, treatment should be discontinued and appropriate therapy instituted.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using Ciclopirox Olamine Cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.at 1-800-922-1038 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.