Dr.forhair Folligen Volume Treatment
Pyrithione Zinc, Salicylic Acid
Wyatt Co., Ltd.
Human Otc Drug
NDC 81736-0002Dr.forhair Folligen Volume Treatment also known as Pyrithione Zinc, Salicylic Acid is a human otc drug labeled by 'Wyatt Co., Ltd.'. National Drug Code (NDC) number for Dr.forhair Folligen Volume Treatment is 81736-0002. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Dr.forhair Folligen Volume Treatment drug includes Pyrithione Zinc - .95 g/100mL Salicylic Acid - 2 g/100mL . The currest status of Dr.forhair Folligen Volume Treatment drug is Active.
Drug Information:
| Drug NDC: | 81736-0002 |
| 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: | Dr.forhair Folligen Volume Treatment |
| 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: | Pyrithione Zinc, Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wyatt Co., Ltd. |
| 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: | PYRITHIONE ZINC - .95 g/100mL
SALICYLIC ACID - 2 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: | 12 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | 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, 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: | Wyatt Co., Ltd.
|
| 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: | R953O2RHZ5
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 |
|---|
| 81736-0002-2 | 1 BOTTLE, PUMP in 1 CARTON (81736-0002-2) / 750 mL in 1 BOTTLE, PUMP (81736-0002-1) | 12 Nov, 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:
Anti-dandruff
Product Elements:
Dr.forhair folligen volume treatment pyrithione zinc, salicylic acid water dipropylene glycol medium-chain triglycerides cetostearyl alcohol cetyl alcohol stearyl alcohol behentrimonium chloride behentrimonium methosulfate docosanol glyceryl monostearate trimethyl octadecyl ammonium chloride quaternium-33 alcohol pentylene glycol propylene glycol isopropyl myristate panthenol propanediol citric acid monohydrate butylene glycol menthol, unspecified form guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) caprylyl glycol lanolin acid ethylhexylglycerin edetate disodium anhydrous cnidium officinale root asian ginseng sodium citrate, unspecified form hydrolyzed soy protein (enzymatic; 2000 mw) zinc chloride sorbitol iris domestica root swertia japonica whole flowering glycerin coconut oil gardenia taitensis flower glycine paeonia x suffruticosa root serine glutamic acid nymphaea alba flower saw palmetto hibiscus sabdariffa flower aspartic acid leucine fagraea berteroana flower cananga odorata flower alanine lysine arginine tyrosine phenylalanine urea polysorbate 80 threonine proline valine isoleucine 1,2-hexanediol ceramide np histidine methionine cysteine cysteic acid, l- sodium succinate hexahydrate plumeria alba flower plumeria rubra flower biotin tocopherol pyrithione zinc pyrithione zinc salicylic acid salicylic acid
Indications and Usage:
Helps prevent recurrence of flaking and itching associated with dandruff
Warnings:
For external use only. when using this product, do not get into eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Dosage and Administration:
After shampooing, apply an appropriate amount evenly from scalp to ends. leave on for 2-3 minutes. rinse thoroughly with lukewarm water. can be used everyday as conditioner.
Package Label Principal Display Panel:
Package label