warnings
WARNINGS Ciclopirox Shampoo, 1% is not for ophthalmic, oral, or intravaginal use. Keep out of reach of children.
FDA label 0baac2f4-9992-4011-b702-8c8cd26bdc27
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
- 2c065e90-9791-4a2b-a8cd-c743d995fe44
- SPL ID
- 0baac2f4-9992-4011-b702-8c8cd26bdc27
- Version
- 2
- Effective date
- 2013-12-03
- Source export date
- 2026-10-12
- 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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:30:23
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 | 0baac2f4-9992-4011-b702-8c8cd26bdc27 | id | |
| spl set id | 2c065e90-9791-4a2b-a8cd-c743d995fe44 | 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 626 patients treated with Ciclopirox Shampoo, 1% twice weekly in the two pivotal clinical studies, the most frequent adverse events were increased itching in 1% of patients, and application site reactions, such as burning, erythema, and itching, also in 1% of patients. Other adverse events occurred in individual patients only. Adverse events that led to early study medication termination in clinical trials occurred in 1.5% (26/1738) of patients treated with Ciclopirox Shampoo, 1% and 2.0% (12/661) of patients treated with shampoo vehicle. The most common adverse event leading to termination of study medication in either group was seborrhea. In the Ciclopirox Shampoo, 1% group, other adverse events included rash, pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.