Lice Treatment
Permethrin
Cvs Pharmacy
Human Otc Drug
NDC 59779-769Lice Treatment also known as Permethrin is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Lice Treatment is 59779-769. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Lice Treatment drug includes Permethrin - 1 mg/100mL . The currest status of Lice Treatment drug is Active.
Drug Information:
| Drug NDC: | 59779-769 |
| 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: | Lice Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 1 mg/100mL
|
| 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: | 03 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | ANDA076090 |
| 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 250387
|
| 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 |
|---|
| 59779-769-26 | 2 BOTTLE in 1 CARTON (59779-769-26) / 59 mL in 1 BOTTLE | 03 May, 2016 | 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. |
Purpose:
Purpose lice treatment
Product Elements:
Lice treatment permethrin permethrin permethrin balsam fir leafy twig anhydrous citric acid butylparaben ceteth-10 cetyl alcohol ethylparaben fd&c yellow no. 6 isopropyl alcohol methylparaben phenoxyethanol propylene glycol propylparaben water stearalkonium chloride
Indications and Usage:
Uses treats head lice
Warnings:
Warnings for external use only do not use ⢠on children under 2 months of age ⢠near the eyes ⢠inside the nose, ear, mouth, or vagina ⢠on lice in eyebrows or eyelashes. see your doctor. ask a doctor before use if you are ⢠allergic to ragweed. may cause breathing difficulty or an asthmatic episode. when using this product ⢠keep eyes tightly closed and protect eyes with a washcloth or towel ⢠if product gets into the eyes, immediately flush with large amounts of water ⢠scalp itching or redness may occur stop use and see a doctor if ⢠breathing difficulty occurs ⢠eye irritation occurs ⢠skin or scalp irritation continues or infection occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
Do Not Use:
Warnings for external use only do not use ⢠on children under 2 months of age ⢠near the eyes ⢠inside the nose, ear, mouth, or vagina ⢠on lice in eyebrows or eyelashes. see your doctor. ask a doctor before use if you are ⢠allergic to ragweed. may cause breathing difficulty or an asthmatic episode. when using this product ⢠keep eyes tightly closed and protect eyes with a washcloth or towel ⢠if product gets into the eyes, immediately flush with large amounts of water ⢠scalp itching or redness may occur stop use and see a doctor if ⢠breathing difficulty occurs ⢠eye irritation occurs ⢠skin or scalp irritation continues or infection occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
When Using:
When using this product ⢠keep eyes tightly closed and protect eyes with a washcloth or towel ⢠if product gets into the eyes, immediately flush with large amounts of water ⢠scalp itching or redness may occur
Dosage and Administration:
Directions inspect ⢠all household members should be checked by another person for lice and/or nits (eggs) ⢠use a magnifying glass in bright light to help you see the lice and nits (eggs) ⢠use a tool, such as a comb or two unsharpened pencils to lift and part the hair ⢠look for tiny nits near the scalp, beginning at the back of the neck and behind the ears ⢠small sections of hair (1-2 inches wide) should be examined at a time ⢠unlike dandruff, nits stick to the hair. dandruff should move when lightly touched. ⢠if either lice or nits (eggs) are found, treat with the creme rinse treat ⢠wash hair with a shampoo without conditioner. do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of the creme rinse. rinse with water. ⢠towel dry hair so it is damp but not wet ⢠shake the bottle well ⢠completely saturate the hair and scalp with the creme rinse. begin to apply the creme
Read more... rinse behind the ears and at the back of the neck. ⢠keep the creme rinse out of the eyes. protect the eyes with a washcloth or towel. ⢠leave the creme rinse on the hair for 10 minutes, but no longer ⢠rinse with warm water ⢠towel dry hair and comb out tangles ⢠if live lice are seen seven days or more after the first treatment, a second treatment should be given remove lice/nits ⢠remove nits by combing the hair with the special small tooth comb provided. remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. ⢠use the nit comb provided and make sure the hair remains slightly damp while removing nits ⢠if the hair dries during combing, dampen it slightly with water ⢠part the hair into 4 sections. work on one section at a time. longer hair may take more time (1-2 hours). ⢠start at the top of the head on the section you have picked ⢠with one hand, lift a 1-2 inch wide strand of hair. get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. ⢠use clips to pin back each strand of hair after you have combed out the nits ⢠clean the comb completely as you go. wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. ⢠after combing, recheck the entire head for nits and repeat combing if necessary ⢠check the affected head daily to remove any nits that you might have missed
Stop Use:
Stop use and see a doctor if ⢠breathing difficulty occurs ⢠eye irritation occurs ⢠skin or scalp irritation continues or infection occurs
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in nix® creme rinse permethrin lotion 1% lice treatment creme rinse with a single application kills lice and their eggs single application prevents reinfestation for 14 days safe, approved for use on children over 2 months of age 2 bottles creme rinse and 2 nit removal combs twin pack 2 nit removal combs included 2-2 fl oz (59 ml) bottles total 4 fl oz (118 ml) 955-17-lice treatment-1.jpg
Further Questions:
Questions or comments? 1-800-719-9260