Lice Killing
Piperonyl Butoxide, Pyrethrum Extract
Weeks & Leo Co., Inc.
Human Otc Drug
NDC 11383-310Lice Killing also known as Piperonyl Butoxide, Pyrethrum Extract is a human otc drug labeled by 'Weeks & Leo Co., Inc.'. National Drug Code (NDC) number for Lice Killing is 11383-310. 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: | 11383-310 |
| 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: | Weeks & Leo Co., Inc. |
| 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: | 17 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | Weeks & Leo Co., Inc.
|
| 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. |
| UPC: | 7323635321092
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 11383-310-02 | 1 BOTTLE in 1 CARTON (11383-310-02) / 59 mL in 1 BOTTLE | 17 May, 2021 | 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 killing piperonyl butoxide, pyrethrum extract piperonyl butoxide piperonyl butoxide pyrethrum extract pyrethrum extract polyquaternium-10 (400 mpa.s at 2%) ammonium laureth-2 sulfate alcohol water peg-25 hydrogenated castor oil cloudy to transparent , cream to straw
Indications and Usage:
Uses treats head, pubic (crab), and body lice
Warnings:
Warnings 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 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:
Warnings 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 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
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 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 o
Read more...ne section 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
Spl Patient Package Insert:
Package insert insert insert
Package Label Principal Display Panel:
Principal display panel lice killing shampoo for the treatment of head lice, pubic (crab) lice and body lice directions important: read warnings before using this product. a second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits) inspect examine each household member with a magnifying glass in bright light for lice/eggs (nits) look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears examine small sections of hair eggs (nits) stick to the hair if either lice or eggs (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 use warm water to form a lather, shampoo, then thoroughly rinse for head lice, towel dry hair and comb out tangles to remove lice and their eggs (nits) use a special lice/nit or fine-toothed comb (included). remove any remaining eggs (nits) by hand, using a throwaway glove hair should remain slightly damp while removing eggs (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 the head. longer hair may take 1 to 2 hours lift a 1- to 2-inch wide strand of hair. place comb firm, even motion away from scalp pin back each strand of hair after combing clean comb often. wipe eggs (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/eggs (nits). repeat combing if necessary check daily for any lice/eggs (nits) that you missed a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits) if infestation continues, see a doctor for other treatments 1. head lice head lice lay small white eggs (nits) on the hair shaft close to the scalp eggs (nits) are most easily found on the back of the neck or behind the ears disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 c (130 f)], then using the hottest dryer setting for at least 20 minutes 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 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 2. pubic (crab) lice pubic (crab) lice may be contracted by sexual contact sexual partners should be treated simultaneously to avoid reinfestation lice are very small and look like brown or grey dots on the skin pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache disinfect underwear by machine washing in hot water [above 54 c (130 f)], then using the hottest dryer setting for at least 20 minutes 3. body lice body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas body lice feed on skin then return to clothing to lay their eggs (nits) disinfect clothing by machine washing in hot water [above 54 c (130 f)], then using the hottest dryer setting for at least 20 mintues do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 days save this insert for future reference carton