NDC 0113-0108 Good Sense Complete Lice Treatment Kit

Piperonyl Butoxide,Pyrethrum Extract Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0113-0108
Proprietary Name:
Good Sense Complete Lice Treatment Kit
Non-Proprietary Name: [1]
Piperonyl Butoxide, Pyrethrum Extract
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
L. Perrigo Company
Labeler Code:
0113
FDA Application Number: [6]
part358G
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
11-20-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 0113-0108-62

Package Description: 1 KIT in 1 CARTON * 59 mL in 1 BOTTLE, PUMP * 118 mL in 1 BOTTLE

Product Details

What is NDC 0113-0108?

The NDC code 0113-0108 is assigned by the FDA to the product Good Sense Complete Lice Treatment Kit which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Complete Lice Treatment Kit is piperonyl butoxide, pyrethrum extract. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0113-0108-62 1 kit in 1 carton * 59 ml in 1 bottle, pump * 118 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Good Sense Complete Lice Treatment Kit?

•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 productTreat•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 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 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 treatmentsChildren under 2 years: ask a doctor

Which are Good Sense Complete Lice Treatment Kit UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Good Sense Complete Lice Treatment Kit Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Good Sense Complete Lice Treatment Kit?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 283219 - piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated Shampoo
  • RxCUI: 283219 - piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo

* Please review the disclaimer below.

Patient Education

Pyrethrin and Piperonyl Butoxide Topical


Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".