FDA label 44ec667d-6e2e-15f0-e054-00144ff8d46c
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
- 3f57a849-1978-4c80-b985-e299e5db9188
- SPL ID
- 44ec667d-6e2e-15f0-e054-00144ff8d46c
- Version
- 2
- Effective date
- 2016-12-30
- Source export date
- 2026-09-28
- 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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:50:25
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 | 44ec667d-6e2e-15f0-e054-00144ff8d46c | id | |
| spl set id | 3f57a849-1978-4c80-b985-e299e5db9188 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS If hypersensitivity to permethrin cream occurs, discontinue use.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In clinical trials, generally mild and transient burning and stinging followed application with permethrin cream in 10% of patients and was associated with the severity of infestation. Pruritis was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS : General ).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.