Vanalice

Piperonyl Butoxide, Pyrethrum

Gm Pharmaceuticals, Inc
Human Otc Drug
NDC 58809-650

Vanalice also known as Piperonyl Butoxide, Pyrethrum is a human otc drug labeled by 'Gm Pharmaceuticals, Inc'. National Drug Code (NDC) number for Vanalice is 58809-650. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Vanalice drug includes Piperonyl Butoxide - 35 mg/mL Pyrethrum Extract - 3 mg/mL . The currest status of Vanalice drug is Active.

Drug Information:

Drug NDC:	58809-650
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:	Vanalice
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:	Piperonyl Butoxide, Pyrethrum
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Gm Pharmaceuticals, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	PIPERONYL BUTOXIDE - 35 mg/mL PYRETHRUM EXTRACT - 3 mg/mL
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:	OTC MONOGRAPH FINAL
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:	05 Aug, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Jun, 2026
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:	part358G
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:	GM Pharmaceuticals, INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2058503 2058508
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.
UNII:	LWK91TU9AH ZUM06L90GV
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
58809-650-08	237 mL in 1 BOTTLE (58809-650-08)	05 Aug, 2018	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.

Other medicines with the same generic name

Vanalice

Piperonyl Butoxide, Pyrethrum

Gel
GM Pharmaceuticals, INC
NDC: 58809-650

Purpose:

Purpose lice treatment

Product Elements:

Vanalice piperonyl butoxide, pyrethrum carbomer interpolymer type a (55000 cps) citronellyl acetate coconut oil dmdm hydantoin polyoxyl 40 hydrogenated castor oil isopropyl myristate west indian lemongrass oil water sodium hydroxide tea tree oil piperonyl butoxide piperonyl butoxide pyrethrum extract pyrethrum extract

Indications and Usage:

Uses treats head, pubic (crab), and body lice

Warnings:

Warnings for external use only do not use near eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. see a doctor if lice are present in these areas. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you are allergic to ragweed. may cause breathing difficulty or an asthmatic attack. when using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur

Dosage and Administration:

Directions important: read warnings before use adults and children 2 years and over: inspect check each household member with a magnifying glass in bright light for lice/nits (eggs) look for tiny nits near scalp, beginning at back of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product treat apply thoroughly to dry hair or other affected area. for head lice, first apply behind ears and to back of neck. allow product to remain for 10 minutes, but no longer wash area thoroughly with warm water and soap or shampoo for head lice, towel dry hair and comb out tangles remove lice and their eggs (nits) use a fine-tooth or special lice/nit comb. remove any remaining nits by hand (using a throw-away glove). hair should remain slightly damp while removing nits if hair dries during combing, dampen slightly with water for head lice, part hair into sections. do one sect Read more...

ion at a time starting on top of the head. longer hair may take 1 to 2 hours. lift a 1-to 2-inch wide strand of hair. place comb as close to scalp as possible and comb with a firm, even motion away from scalp. pin back each strand of hair after combing clean comb often. wipe nits away with tissue and discard in a plastic bag. seal bag and discard to prevent lice from coming back. after combing, thoroughly recheck for lice/nits. repeat combing if necessary. check daily for any lice/nits that you missed a second treatment must be done in 7 to 10 days to kill any newly hatched lice if infestation continues, see a doctor for other treatments children under 2 years: ask a doctor

Stop Use:

Stop use and ask 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 ndc 58809-650-08 vana liceâ¢ lice killing gel lice treatment one nit comb included 8 fl oz (237 ml) principal display panel ndc 58809-650-08 vanalice lice killing gel lice treatment one nit comb included 8 fl oz (237 ml)

Further Questions:

Questions or comments? 1-888-535-0305 monday-friday 9 am - 5 pm cst step 1 : treat vanaliceâ¢ lice killing gel see usage guidelines to see how much product you will need. note: use towels to protect child's eyes from treatment and prevent clothes from getting wet. apply lice killing gel thoroughly to dry hair or other affected area. wetting the hair dilutes the treatment making it less effective. also, lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice. for head lice, thoroughly massage gel into scalp, behind the ears and to the back of the neck. lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair allow product to remain on the hair (or other affected area) for 10 minutes, but no longer. wash area thoroughly with warm water and soap or shampoo for head lice, towel dry hair and comb out tangles proceed to step 2 a second treatment must be done in 7 to 10 days to kill any newly-hatched lice. step 2: remove lice/nit comb combing must be done after use of vanaliceâ¢ lice killing gel (step 1). combing out eggs & nits* is an essential step to complete lice elimination. note: a fine-toothed comb or the special lice/nit removing comb (included) must be used to remove lice, eggs, and nits from hair. before starting have on hand - extra towels - bobby pins or hair clips - facial tissues or paper towels - regular comb for parting and detangling hair - detangler/conditioner to make combing easier find a distraction for your child (e.g. books, tv, game). when combing, use the fine-tooth lice/nit comb provided and make sure the teeth are facing you part hair into sections. working one section at a time, lift a 1- to 2- inch wide strand of hair place comb as a close to the scalp as possible and comb with a firm, even motion away from scalp, from the roots to the end of the hair (newly-laid eggs are found near the roots of the hair so it is important to get the teeth very close to the scalp). make sure the teeth are deeply embedded into the strands as you comb through. always comb away from the head. wipe eggs and nits from the teeth of the comb with a tissue or paper towel. remove any remaining nits by hand (using a throw-away-glove). pin back the 1- to 2-inch wide strand you just finished combing with a bobby pin or hair clip. lift up another 1- to 2-inch wide strand and repeat the combing procedure. when one section has been combed and pinned, repeat the process for another section of hair. continue to comb hair 1- to 2-inches at a time until entire head has been combed and pinned. keep the hair damp during combing and re-apply detangler/conditioner as needed. after you have combed and pinned the entire head, remove all bobby pins or hair clips and rinse hair thoroughly with warm water. if desired, you may also wash with regular shampoo. discard all the used tissues or paper towels into a bag, seal and dispose to prevent lice from coming back. *nits are empty eggshells left behind when lice hatch from eggs. step 3 â control head lice lay small white eggs (nits) on hair shaft close to scalp. nits are most easily found on back of neck or behind ears. disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water [above 54Â°c (130Â°f)], then using hottest dryer cycle for at least 20 minutes. items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry- cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again. items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose. soak all combs and brushes in hot water [above 54Â°c (130Â°f)] for at least 10 minutes. vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people. pubic (crab) lice may be transmitted by sexual contact. sexual partners should be treated simultaneously to avoid reinfestation. lice are very small and look like brown or grey dots on skin. usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface. may be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache. disinfect underwear by machine washing in hot water [above 54Â°c (130Â°f)], then using hottest dryer cycle for at least 20 minutes. body lice body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area. body lice feed on skin then return to clothing to lay their eggs. disinfect clothing by machine washing in hot water [above 54Â°c (130Â°f)], then using hottest dryer cycle for at least 20 minutes. do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days. daily checking to prevent reinfestation: carefully inspect infested family member daily for at least 2 weeks. if you see eggs or nits, repeat step 2. check other family members for head lice. if anyone in the family is infested, follow step 1 and step 2. repeat step 3 with any articles or items with which they have come into contact. checklist - home and auto upholstery - bike/sport helmets - mattresses, pillows, pillowcases - coats, scarves, earmuffs, gloves - bed linen - play mats - towels - clothing - stuffed animals, toys - barrettes/hair ornaments - headphones - hair rollers - hats - combs and brushes - headbands - baseball caps

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.