Rid Lice Treatment Complete Kit
Piperonyl Butoxide, Pyrethrum Extract
Oystershell Consumer Health Inc
Human Otc Drug
NDC 82392-101Rid Lice Treatment Complete Kit also known as Piperonyl Butoxide, Pyrethrum Extract is a human otc drug labeled by 'Oystershell Consumer Health Inc'. National Drug Code (NDC) number for Rid Lice Treatment Complete Kit is 82392-101. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Rid Lice Treatment Complete Kit drug includes . The currest status of Rid Lice Treatment Complete Kit drug is Active.
Drug Information:
| Drug NDC: | 82392-101 |
| 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 Treatment Complete Kit |
| 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: | Oystershell Consumer Health Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 23 Jun, 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: | |
| 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 |
|---|
| 82392-101-04 | 1 KIT in 1 CARTON (82392-101-04) * 1 BOTTLE in 1 CARTON (82392-100-04) / 118 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:
Purpose lice treatment
Product Elements:
Rid lice treatment complete kit piperonyl butoxide, pyrethrum extract 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 cloudy to transparent, cream to straw carton label carton label
Indications and Usage:
Uses treats head, pubic (crab), and body lice
Warnings:
Warnings for external use only do not use near the eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. see a doctor if lice are present in these areas. if you have ever had an allergic reaction to this product or any of its ingredients 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.
Do Not Use:
Warnings for external use only do not use near the eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. see a doctor if lice are present in these areas. if you have ever had an allergic reaction to this product or any of its ingredients 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.
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 â â 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 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 the rid® lice 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
Read more... 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 rid ® lice treatment complete kit lice treatment easy-to-follow 3-step processâ instructions inside â treat â¡ remove ⢠control rid support call an expert 1-800-rid-lice how-to videos tratamiento de piojosâkit completo se incluyen instrucciones en español keep out of reach of children caution see back panel for additional precautions shampoo net wt. 4 fl oz (118 ml) comb-out spray net wt. 2 fl oz (59 ml) rid ® home lice, bedbug & dust mite spray net wt. 3 oz (85.1 g) 1 patented rid ® lice comb rid® provides everything you need to treat lice in your family and in your home. step 1 treat apply rid ® lice killing shampoo according to label directions. repeat this step 7 to 10 days later to kill any newly hatched lice. step 2 remove after step 1, apply a small amount of rid ® lice & egg comb-out spray and use a wide-tooth comb to remove any tangles. comb out the eggs and nits in the hair with rid ® lice comb (included), using additional spray to remove tangles if needed. step 3 control use rid ® home lice, bedbug & dust mite spray to kill lice and their eggs on mattresses, furniture, car interiors, and other non-washable items. important: read detailed directions inside before using. this kit contains 4 products (lice killing shampoo, lice & egg comb-out spray, lice comb and rid ® home lice, bedbug & dust mite spray to treat lice in your family and home. the 4oz. bottle of shampoo and 2oz bottle of comb-out spray should be enough product to treat one person one time. however, the amount of shampoo needed will vary by hair length and you may need additional shampoo for the second treatment 7 to 10 days later. see below for guidelines. lice killing shampoo hair length approximate amount for 1 adult/child: short (ear length or shorter) first application: 1 oz - 2 oz second application: 1 oz - 2 oz total: 2 oz - 4 oz medium (shoulder length) first application: 2 oz - 3 oz second application: 2 oz - 3 oz total: 4 oz - 6 oz long (past shoulder length) first application: 3 oz - 4 oz second application: 3 oz - 4 oz total: 6 oz - 8 oz
Further Questions:
Questions or comments? 1-800-rid-lice (1-800-743-5423)