warnings
WARNINGS If hypersensitivity to Permethrin Cream 5% w/w occurs, discontinue use.
Permethrin
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
- Permethrin
- Generic name
- PERMETHRIN CREAM 5% W/W
- Manufacturer
- REMEDYREPACK INC.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e3d77092-dad6-4df5-ac39-ff9dc8f5758c
- SPL ID
- 4ab97b94-fb1e-2d2e-e063-6294a90a11ec
- Version
- 13
- Effective date
- 2026-02-13
- 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 05:47:03
| 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 | 211303 | derived:openfda.application_number |
| application number | ANDA211303 | openfda.application_number | |
| brand name | Permethrin | openfda.brand_name | |
| generic name | PERMETHRIN CREAM 5% W/W | openfda.generic_name | |
| manufacturer name | REMEDYREPACK INC. | openfda.manufacturer_name | |
| ndc | package | 70518-2945-0 | openfda.package_ndc |
| ndc | product | 70518-2945 | openfda.product_ndc |
| ndc11 | package | 70518294500 | derived:openfda.package_ndc |
| rxcui | 106387 | openfda.rxcui | |
| spl id | 4ab97b94-fb1e-2d2e-e063-6294a90a11ec | id | |
| spl set id | e3d77092-dad6-4df5-ac39-ff9dc8f5758c | set_id | |
| unii | 509F88P9SZ | openfda.unii |
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, generally mild and transient burning and stinging followed application with Permethrin Cream 5% w/w in 10% of patients and was associated with the severity of infestation. Pruritus 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 ). Other adverse events reported since marketing Permethrin Cream 5% w/w include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream 5% w/w treatment.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.