NDC 11383-310 Lice Killing

Piperonyl Butoxide, Pyrethrum Extract

NDC Product Code 11383-310

NDC CODE: 11383-310

Proprietary Name: Lice Killing What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Piperonyl Butoxide, Pyrethrum Extract What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Permethrin is also used to help avoid infestation in people who have close contact with someone who has head lice. It belongs to a class of drugs known as pyrethrins. Permethrin works by paralyzing and killing lice and their eggs (nits).

Product Characteristics

Color(s):
YELLOW (C48330 - CLOUDY TO TRANSPARENT , CREAM TO STRAW)

NDC Code Structure

  • 11383 - Weeks & Leo Co., Inc.

NDC 11383-310-02

Package Description: 1 BOTTLE in 1 CARTON > 59 mL in 1 BOTTLE

NDC Product Information

Lice Killing with NDC 11383-310 is a a human over the counter drug product labeled by Weeks & Leo Co., Inc.. The generic name of Lice Killing is piperonyl butoxide, pyrethrum extract. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Weeks & Leo Co., Inc.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lice Killing Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PIPERONYL BUTOXIDE 4 g/100mL
  • PYRETHRUM EXTRACT .33 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
  • AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Weeks & Leo Co., Inc.
Labeler Code: 11383
FDA Application Number: part358G What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-17-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lice Killing Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Piperonyl butoxide 4%Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

Treats head, pubic (crab), and body lice

Purpose

Lice treatment

Do Not Use

  • Near eyesinside 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 towelif product gets into eyes, flush with water right awayscalp itching or redness may occur

Stop Use And Ask A Doctor If

  • Breathing difficulty occurseye irritation occursskin 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

Directions

  • Important: Read warnings before use
  • Adults and children 2 years and over:
  • Inspectcheck 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 earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this productTreatapply 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 longeruse warm water to form a lather, shampoo, then thoroughly rinsefor head lice, towel dry hair and comb out tanglesRemove 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 nitsif hair dries during combing, dampen slightly with waterfor 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 as close to scalp as possible and comb with a firm, even motion away from scalp.pin back each strand of hair after combingclean 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 misseda second treatment must be done in 7 to 10 days to kill any newly hatched liceif infestation continues, see a doctor for other treatmentsChildren under 2 years: ask a doctor

Other Information

  • Do not freezestore at controlled room temperature 20°-25°C (68°-77°F)to report serious side effects due to the use of this product call 515-276-1586see package insert for additional information

Inactive Ingredients

Ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

* Please review the disclaimer below.