Arca Regeneration Head Spa
Pinus Radiata Bark Extract, Menthol, Salicylic Acid
Hair Arca, Inc
Human Otc Drug
NDC 83104-301Arca Regeneration Head Spa also known as Pinus Radiata Bark Extract, Menthol, Salicylic Acid is a human otc drug labeled by 'Hair Arca, Inc'. National Drug Code (NDC) number for Arca Regeneration Head Spa is 83104-301. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Arca Regeneration Head Spa drug includes Salicylic Acid - .5 g/100mL . The currest status of Arca Regeneration Head Spa drug is Active.
Drug Information:
| Drug NDC: | 83104-301 |
| 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: | Arca Regeneration Head Spa |
| 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: | Pinus Radiata Bark Extract, Menthol, Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hair Arca, 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 - .5 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: | 03 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | M032 |
| 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: | Hair Arca, 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: | O414PZ4LPZ
|
| 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 |
|---|
| 83104-301-01 | 503 mL in 1 BOTTLE, PUMP (83104-301-01) | 03 Oct, 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 pinus radiata bark extract 0.05% - skin protectant menthol 0.5% - dandruff control salicylic acid 0.5% - dandruff control
Product Elements:
Arca regeneration head spa pinus radiata bark extract, menthol, salicylic acid citric acid monohydrate stearyl alcohol propylene glycol monarda didyma leaf mentha piperita leaf chamomile rosemary freesia alba whole ethylhexylglycerin oat salicylic acid salicylic acid ppg-10 caprylyl ether castor oil sunflower oil behentrimonium methosulfate panthenol hydroxyethyl cellulose, unspecified gelatin hydrolyzed wheat protein (enzymatic, 3000 mw) edetate disodium anhydrous camellia japonica seed oil hydrolyzed soy protein (enzymatic; 2000 mw) cetrimonium chloride water trimethyl octadecyl ammonium chloride lavandula angustifolia subsp. angustifolia flower cetyl alcohol stearamidopropyl dimethylamine sodium benzoate 1,2-hexanediol allantoin butylene glycol caprylyl glycol
Indications and Usage:
Uses helps to keep scalp healthy by controlling follicle and protecting skin. if used together with other arca hair products, helps hair enrichment and decreases the risks of hair loss and various scalp troubles.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
Warnings when using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions arca regeneration head spa recommends the following instructions for scalp improvement and skin troubles. (head spa is recommended to use 2~3 times a week) 1 shampoo your hair with arca shampoo before using the head spa 2 use 1-3 pumps to massage your scalp and hair. then wait 2 to 3 minutes. 3 rinse thoroughly with warm water.
Stop Use:
Warnings stop use and ask doctor if conditions worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Display panel 83104-401 arca regeneration head spa_label