warnings
WARNINGS: Ciclopirox gel 0.77% is not for ophthalmic, oral, or intravaginal use. Keep out of reach of children.
FDA label 1d32ad61-ede9-46b8-af8e-37acf0a86ded
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
- 88324009-d5cc-4982-be3e-058e0436f608
- SPL ID
- 1d32ad61-ede9-46b8-af8e-37acf0a86ded
- Version
- 7
- Effective date
- 2026-09-03
- Source export date
- 2026-11-06
- 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/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:49:32
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 | 1d32ad61-ede9-46b8-af8e-37acf0a86ded | id | |
| spl set id | 88324009-d5cc-4982-be3e-058e0436f608 | 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 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.