Permethrin
Actavis Pharma, Inc.
Human Prescription Drug
NDC 0472-0242Permethrin is a human prescription drug labeled by 'Actavis Pharma, Inc.'. National Drug Code (NDC) number for Permethrin is 0472-0242. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Permethrin drug includes Permethrin - 50 mg/g . The currest status of Permethrin drug is Active.
Drug Information:
| Drug NDC: | 0472-0242 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Permethrin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Permethrin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Actavis Pharma, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PERMETHRIN - 50 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Nov, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA074806 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Actavis Pharma, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106387
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | M0018228
N0000175847
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 509F88P9SZ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Pyrethroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Pyrethrins [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Pyrethrins [CS]
Pyrethroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0472-0242-60 | 1 TUBE in 1 CARTON (0472-0242-60) / 60 g in 1 TUBE | 30 Nov, 2004 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Permethrin permethrin permethrin permethrin butylated hydroxytoluene carbomer 934 coconut oil glycerin glyceryl monostearate isopropyl myristate lanolin alcohols light mineral oil ceteth-10 ceteth-20 water sodium hydroxide formaldehyde
Indications and Usage:
Indications and usage permethrin cream is indicated for the treatment of infestation with sarcoptes scabiei (scabies).
Warnings:
Warnings if hypersensitivity to permethrin cream occurs, discontinue use.
General Precautions:
General scabies infestation is often accompanied by pruritis, edema and erythema. treatment with permethrin cream may temporarily exacerbate these conditions.
Dosage and Administration:
Dosage and administration adults and children: thoroughly massage permethrin cream 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.
Contraindications:
Contraindications permethrin cream 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 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 ).
Overdosage:
Overdosage no instance of accidental ingestion of permethrin cream has been reported. if ingested, gastric lavage and general supportive measures should be employed.
Description:
Description permethrin cream 5% is a topical scabicidal agent for the treatment of infestation with sarcoptes scabiei (scabies). it is available in a white to off-white, vanishing cream base. permethrin cream is for topical use only. structural formula: chemical name: the permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)- 2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. permethrin has a molecular formula of c 21 h 20 cl 2 o 3 and a molecular weight of 391 . 29. it is a yellow to light orange-brown, low melting solid or viscous liquid. each gram contains permethrin 50 mg (5%) and the inactive ingredients butylated hydroxytoluene, carbomer 934p, coconut oil, glycerin, glyceryl stearate, isopropyl myristate, lanolin alcohols, light mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. formaldehyde 1 mg (0 . 1%) is added as a preservative. fc7b7123-figure-01
Clinical Pharmacology:
Clinical pharmacology permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. it acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. delayed repolarization and paralysis of the pests are the consequences of this disturbance. permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14 c-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.
How Supplied:
How supplied permethrin cream 5% (wt./wt.) is supplied in 60 g tubes. store at room temperature 15°-25°c (59°-77°f). distributed by: actavis pharma, inc. parsippany, nj 07054 usa rev. a 12/2019
Package Label Principal Display Panel:
Package label.principal display panel actavis ndc 0472-0242-60 permethrin cream 5% w/w rx only for external use only not for use in eyes 60g (2.2 oz) 1