Liceout

Piperonyl Butoxide And Pyrethrum Extract

Bob Barker Company Inc.
Human Otc Drug
NDC 53247-124

Liceout also known as Piperonyl Butoxide And Pyrethrum Extract is a human otc drug labeled by 'Bob Barker Company Inc.'. National Drug Code (NDC) number for Liceout is 53247-124. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Liceout drug includes Piperonyl Butoxide - 3 g/100mL Pyrethrum Extract - .3 g/100mL . The currest status of Liceout drug is Active.

Drug Information:

Drug NDC:	53247-124
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:	Liceout
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 And Pyrethrum Extract
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bob Barker Company 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 - 3 g/100mL PYRETHRUM EXTRACT - .3 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:	02 Jan, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 May, 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:	Bob Barker Company Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	283217 2599624
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
53247-124-01	150 PACKET in 1 CASE (53247-124-01) / 29.6 mL in 1 PACKET	02 Jan, 2022	N/A	No
53247-124-02	3785 mL in 1 JUG (53247-124-02)	02 Jan, 2022	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

Rid Lice Killing

Piperonyl Butoxide And Pyrethrum Extract

Shampoo
Oystershell Consumer Health Inc
NDC: 82392-100

Liceout

Piperonyl Butoxide And Pyrethrum Extract

Shampoo
Bob Barker Company Inc.
NDC: 53247-124

Herklin

Piperonyl Butoxide And Pyrethrum Extract

Shampoo
MarcusUSA
NDC: 75940-171

Purpose:

Active ingredients purpose piperonyl butoxide, technical 3.0% lice treatment pyrethrum extract 0.3% lice treatment *equivalent to min. 2.4% (butylcarbityl) (6-propylpiperonyl) ether and 0.6% related compounds.

Product Elements:

Liceout piperonyl butoxide and pyrethrum extract c13-14 isoparaffin octoxynol-9 water benzyl alcohol 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. ask a doctor before use if you are allergic to ragweed. if product gets in eyes, flush with water right away scalp itch-ing 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 children under 2 years ask a doctor. caution keep out of the reach of children

Do Not Use:

Dosage and Administration:

Directions shake well before using adults and children 2 years and over. treat apply thoroughly to 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. check daily for any lice/nits. 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.

Stop Use:

Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs children under 2 years ask a doctor.

Package Label Principal Display Panel:

Principal display panel - 150 sachet case lice outâ¢ shampoo lice treatment 150 sachetsâtotal net weight 180.8 oz (11.3 lbs) (5.12 kg) principal display panel - 150 sachet case

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.