Rid Lice Killing
Piperonyl Butoxide And Pyrethrum Extract
Oystershell Consumer Health Inc
Human Otc Drug
NDC 82392-100Rid Lice Killing also known as Piperonyl Butoxide And Pyrethrum Extract is a human otc drug labeled by 'Oystershell Consumer Health Inc'. National Drug Code (NDC) number for Rid Lice Killing is 82392-100. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Rid Lice Killing drug includes Piperonyl Butoxide - 40 mg/mL Pyrethrum Extract - .033 mg/mL . The currest status of Rid Lice Killing drug is Active.
Drug Information:
| Drug NDC: | 82392-100 |
| 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: | Rid 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 And Pyrethrum Extract |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oystershell Consumer Health 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 - 40 mg/mL
PYRETHRUM EXTRACT - .033 mg/mL
|
| 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 Jan, 2021 |
| 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: | Oystershell Consumer Health Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 82392-100-02 | 1 BOTTLE in 1 CARTON (82392-100-02) / 59 mL in 1 BOTTLE | 05 Jan, 2021 | N/A | No |
| 82392-100-04 | 1 BOTTLE in 1 CARTON (82392-100-04) / 118 mL in 1 BOTTLE | 05 Jan, 2021 | N/A | No |
| 82392-100-08 | 1 BOTTLE in 1 CARTON (82392-100-08) / 237 mL in 1 BOTTLE | 05 Jan, 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:
Product Elements:
Rid lice killing piperonyl butoxide and pyrethrum extract piperonyl butoxide piperonyl butoxide pyrethrum extract pyrethrum extract ammonium laureth-2 sulfate alcohol isopropyl alcohol peg-25 hydrogenated castor oil polyquaternium-10 (125 mpa.s at 2%) water label
Indications and Usage:
Treats head, pubic (crab), and body lice.
Warnings:
Warnings: for external use only do not use near the eyes, inside nose, mouth, vagina, or 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. do not open eyes until product is rinsed out of hair. if product gets in eyes, flush with water right away. stop use and consult 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: for external use only do not use near the eyes, inside nose, mouth, vagina, or 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. do not open eyes until product is rinsed out of hair. if product gets in eyes, flush with water right away. stop use and consult 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. do not open eyes until product is rinsed out of hair. if product gets in eyes, flush with water right away.
Dosage and Administration:
Directions: important: read carton for complete warnings and directions before using. adults and children 2 years and older 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 on hair for 10 minutes, but no longer. use warm water to form a lather, shampoo, then rinse thoroughly. for head lice, towel dry hair and comb out tangles. a fine-tooth comb or a special lice/nit removing comb must be used to help remove lice, eggs, and nits from hair. a second treatment must be done in 7-10 days to kill any newly hatched lice. children under 2 years: ask a doctor
Stop Use:
Stop use and consult 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 rid ® lice killing shampoo lice treatment proven, effective treatment shampoo and conditioner in one east-to-follow illustrated instructions 8 fl oz (236 ml) lot exp b2k1
Further Questions: