Drugplain

Permethrin 50 mg/g

Permethrin · CREAM · Bryant Ranch Prepack

No Recall History
Plain English

Permethrin is a cream containing permethrin at 50 mg/g, taken topical. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Permethrin
Generic Name
Permethrin
NDC Code (Product)
71335-2899
Manufacturer
Bryant Ranch Prepack
Strength
50 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA076369
Drug Class
Pyrethroid [EPC]
Marketing Start
08/11/2006

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective203 reports
off label use109 reports
pruritus95 reports
pain83 reports
chronic kidney disease66 reports
anxiety63 reports
nausea54 reports
rash53 reports
dry skin52 reports
headache50 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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. 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. There are 5 other brand versions of Permethrin.

What is the NDC code for Permethrin 50 mg/g?

The NDC (National Drug Code) for Permethrin 50 mg/g is 71335-2899, listed by Bryant Ranch Prepack.