Lice Killing

Piperonyl Butoxide, Pyrethrum Extract


Major Pharmaceuticals
Human Otc Drug
NDC 0904-2528
Lice Killing also known as Piperonyl Butoxide, Pyrethrum Extract is a human otc drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Lice Killing is 0904-2528. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Lice Killing drug includes Piperonyl Butoxide - 4 g/100mL Pyrethrum Extract - .33 g/100mL . The currest status of Lice Killing drug is Active.

Drug Information:

Drug NDC: 0904-2528
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 Killing
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 Extract
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Major Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Shampoo
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 - 4 g/100mL
PYRETHRUM EXTRACT - .33 g/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: 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: 16 Aug, 2007
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 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: 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:Major Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:283219
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0904-2528-201 BOTTLE in 1 CARTON (0904-2528-20) / 118 mL in 1 BOTTLE16 Aug, 2007N/ANo
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 killing piperonyl butoxide, pyrethrum extract piperonyl butoxide piperonyl butoxide pyrethrum extract pyrethrum extract benzyl alcohol c13-14 isoparaffin water xanthan gum cloudy to transparent, cream to straw

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. 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 in 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 (1-800-222-1222).

Do Not Use:

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. 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 in 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 (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 in 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 • shake well before using • 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 • use warm water to form a lather, shampoo, then thoroughly rinse • 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 • if hair dries during combing, dampen slightly with water • for head lice, part hair into sections. do one section at a time starting on top of 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 compare to the active ingredients in rid® lice killing shampoo maximum strength lice killing shampoo lice treatment 3 step lice control system leaves no chemical residue behind proven safe and effective to kill lice and their eggs 4 fl oz (118 ml) includes 1 comb 8665c-lice-shampoo

Further Questions:

Questions or comments? 1-800-616-2471 consumer information steps to success with 1-2-3 lice control system complete lice control for your family and home. step 1: treat lice killing shampoo see usage guidelines to estimate how much product you will need. note: • shake well before using. • use towels to protect child's eyes from treatment and prevent clothes from getting wet. • apply lice killing shampoo 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 shampoo 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. • add warm water and massage to form a lather. • rinse thoroughly. • 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 lice killing shampoo (step 1). combing out eggs & nits* is an essential step to complete lice control. 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). • apply detangler/conditioner and comb out damp hair with a regular wide-tooth comb to take out snarls and tangles. • hold the lice/nit comb with the teeth facing you. • 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. • 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: control home lice, bedbug & dust mite spray • use home lice, bedbug & dust mite spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items. a regular disinfectant spray will not kill lice and their eggs. • after spraying the infested area, vacuum rugs and carpets. dispose of the vacuum cleaner bags after use. • wash all clothes, towels, washable hats, scarves, coats and bed linens in hot water. dry in high heat for at least 20 minutes. • dry clean non-washables. • personal combs and brushes may be disinfected by soaking in hot water [above 54°c (130°f)] for at least 10 minutes. • place stuffed toys in plastic bags and seal them for 4 weeks. 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 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. second application repeat the same procedures within 7-10 days for step 1: treat and step 2: remove there may be some eggs that were not combed out after the first treatment. these eggs will hatch and need to be killed with the second treatment. did you know? 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 54°c (130°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, such as a home lice, bedbug & dust mite spray. • soak all combs and brushes in hot water [above 54°c (130°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 54°c (130°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 54°c (130°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. distributed by perrigo ® allegan, mi 49010 : 8660000j5 lice killing shampoo drug facts active ingredients piperonyl butoxide 4% pyrethrum extract (equivalent to 0.33% pyrethrins) purpose lice treatment uses treats head, pubic (crab), and body lice 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. 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 in 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 (1-800-222-1222). 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 • shake well before using • 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 • use warm water to form a lather, shampoo, then thoroughly rinse • 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 section at a time starting on top of 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 other information • store at 20-25°c (68-77°f). avoid excessive heat. inactive ingredients benzyl alcohol, c13-c14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gum questions? 800-719-9260 image 1 image 2 image 3 image 4 usage guidelines image image 5 image 6 image 7 image 8


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* 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.