warnings
WARNINGS: General Ciclopirox olamine topical suspension, 1% is not for ophthalmic use. Keep out of reach of children.
FDA label 1120d996-3371-4f36-97ea-586953282896
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
- SPL set ID
- 4aeae21c-8c03-4fa9-a191-6b1e9000cbdb
- SPL ID
- 1120d996-3371-4f36-97ea-586953282896
- Version
- 5
- Effective date
- 2026-09-02
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:00:55
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 |
|---|---|---|---|
| spl id | 1120d996-3371-4f36-97ea-586953282896 | id | |
| spl set id | 4aeae21c-8c03-4fa9-a191-6b1e9000cbdb | set_id |
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 suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox olamine suspension.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.