Topcare Lice Killing
Piperonyl Butoxide, Pyrethrum Extract
Topco Associates Llc
Human Otc Drug
NDC 36800-866Topcare Lice Killing also known as Piperonyl Butoxide, Pyrethrum Extract is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Topcare Lice Killing is 36800-866. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Topcare Lice Killing drug includes Piperonyl Butoxide - 4 g/100mL Pyrethrum Extract - .33 g/100mL . The currest status of Topcare Lice Killing drug is Active.
Drug Information:
| Drug NDC: | 36800-866 |
| 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: | Topcare 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: | Topco Associates Llc |
| 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: | 05 Sep, 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: | Topco Associates LLC
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 36800-866-34 | 1 BOTTLE in 1 CARTON (36800-866-34) / 236 mL in 1 BOTTLE | 10 Sep, 2012 | 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:
Topcare 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 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 (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 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 (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 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 ⢠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
Read more...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
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 topcare health ⢠compare to rid ® lice killing shampoo active ingredients maximum strength lice killing shampoo lice treatment works fast to kill lice & their eggs for treatment of head, crab & body lice 8 fl oz (236 ml) 2 nit removal combs included 866-88-lice-killing-shampoo.jpg
Further Questions:
Questions or comments? 1-888-423-0139