Permethrin 50 mg/g
Permethrin Cream 5% w/w · CREAM · Preferred Pharmaceuticals Inc.
Permethrin is a cream containing permethrin cream 5% w/w at 50 mg/g, taken topical. Manufactured by Preferred Pharmaceuticals Inc..
Key Facts
- Brand Name
- Permethrin
- Generic Name
- Permethrin Cream 5% w/w
- NDC Code (Product)
68788-8439- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 50 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA211303
- Drug Class
- Pyrethroid [EPC]
- Marketing Start
- 06/05/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
Dosage & Administration
DOSAGE AND ADMINISTRATION: Adults and Children - Thoroughly massage Permethrin Cream, 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE. Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.
Warnings
WARNINGS: If hypersensitivity to Permethrin Cream, 5% occurs, discontinue use.
Contraindications
CONTRAINDICATIONS: Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
Adverse Reactions
ADVERSE REACTIONS: In clinical trials, generally mild and transient burning and stinging followed application with Permethrin Cream, 5% 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% 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% treatment.
Frequently Asked Questions
What is Permethrin used for?
Permethrin contains Permethrin Cream 5% w/w. It is a cream taken topical. Consult your doctor for specific uses.
Is Permethrin a controlled substance?
Permethrin is not classified as a controlled substance by the DEA.
What is the generic name for Permethrin?
The generic name for Permethrin is Permethrin Cream 5% w/w. There are no other listed brand versions of Permethrin Cream 5% w/w.
What is the NDC code for Permethrin 50 mg/g?
The NDC (National Drug Code) for Permethrin 50 mg/g is 68788-8439, listed by Preferred Pharmaceuticals Inc..
Other Permethrin Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)