Progenesis
Dandruff And Seborrheic Dermatitis Shampoo
Palcare Enterprises Inc
Human Otc Drug
NDC 82349-140Progenesis also known as Dandruff And Seborrheic Dermatitis Shampoo is a human otc drug labeled by 'Palcare Enterprises Inc'. National Drug Code (NDC) number for Progenesis is 82349-140. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Progenesis drug includes Salicylic Acid - 2 mg/100mL Sulfur - 2 mg/100mL . The currest status of Progenesis drug is Active.
Drug Information:
| Drug NDC: | 82349-140 |
| 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: | Progenesis |
| 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: | Dandruff And Seborrheic Dermatitis Shampoo |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Palcare Enterprises 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: | SALICYLIC ACID - 2 mg/100mL
SULFUR - 2 mg/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: | 01 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | part358H |
| 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, 2024 |
| 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: | Palcare Enterprises 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. |
| UPC: | 0896968000172
|
| UPC stands for Universal Product Code. |
| UNII: | O414PZ4LPZ
70FD1KFU70
|
| 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 |
|---|
| 82349-140-72 | 250 mL in 1 BOTTLE, PLASTIC (82349-140-72) | 01 Feb, 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. |
Purpose:
Purpose dandruff, seborrheic and dermatitis shampoo
Product Elements:
Progenesis dandruff and seborrheic dermatitis shampoo pentaerythrityl tetrastearate cinchona pubescens bark propanediol polyquaternium-7 (70/30 acrylamide/dadmac; 1600 kd) sodium laureth sulfate cocamidopropyl betaine salicylic acid salicylic acid sulfur sulfur peg-150 lanolin ppg-2 hydroxyethyl cocamide sodium benzoate polysorbate 20 citric acid monohydrate sodium chloride coco diethanolamide caffeine plantago lanceolata leaf hedera helix leaf biotin dipropylene glycol panthenol potassium sorbate glycerin 1,2-hexanediol polyoxyl 30 castor oil sodium cocoamphoacetate
Indications and Usage:
Use helps stop the symptoms of dandruff & seborrheic dermatitis
Warnings:
Warnings ⢠for external use only ⢠in case of eye contact, wash immediately
Do Not Use:
Warnings ⢠for external use only ⢠in case of eye contact, wash immediately
Dosage and Administration:
Directions ⢠wet hair with warm water, ⢠apply 4-5 drops of the product, ⢠massage gently into the lather of your scalp and hair and allow to act for a few minutes ⢠subsequently rinse accurately.
Package Label Principal Display Panel:
Package label - principal display panel 250 ml ndc: 82349-140-72 250 ml ndc: 82349-140-72
Further Questions:
Questions (or comments)? call 1-250-590-4850