Evermastic Mastic Scalp Care
Pyrithione Zinc, Salicylic Acid
Mastic Korea.co.ltd
Human Otc Drug
NDC 79814-010Evermastic Mastic Scalp Care also known as Pyrithione Zinc, Salicylic Acid is a human otc drug labeled by 'Mastic Korea.co.ltd'. National Drug Code (NDC) number for Evermastic Mastic Scalp Care is 79814-010. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Evermastic Mastic Scalp Care drug includes Pyrithione Zinc - .202 g/100g Salicylic Acid - .2 g/100g . The currest status of Evermastic Mastic Scalp Care drug is Active.
Drug Information:
| Drug NDC: | 79814-010 |
| 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: | Evermastic Mastic Scalp Care |
| 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: | Mastic Korea.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 - .202 g/100g
SALICYLIC ACID - .2 g/100g
|
| 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: | 24 May, 2022 |
| 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: | Mastic Korea.Co.Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2601741
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| 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 |
|---|
| 79814-010-02 | 1 BOTTLE, PUMP in 1 CARTON (79814-010-02) / 500 g in 1 BOTTLE, PUMP (79814-010-01) | 24 May, 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:
Anti-dandruff
Product Elements:
Evermastic mastic scalp care pyrithione zinc, salicylic acid water sodium c14-16 olefin sulfonate glycerin lauryl betaine cocamidopropyl hydroxysultaine disodium laureth sulfosuccinate lauryl glucoside decyl glucoside coco glucoside laminaria japonica reynoutria multiflora root sargassum fusiforme plocamium cartilagineum urtica dioica leaf purslane phyllostachys nigra leaf houttuynia cordata flowering top eclipta prostrata leaf centella asiatica triterpenoids sophora flavescens root bombyx mori fiber asarum sieboldii root angelica gigas root platycladus orientalis leaf lycium chinense fruit ginkgo safflower sambucus nigra flower rosa x damascena flower rosa centifolia flower rosa canina flower lavandula angustifolia subsp. angustifolia flower hibiscus sabdariffa flower calendula officinalis flower bellis perennis flower arnica montana flower chamaemelum nobile flower ulmus davidiana root pueraria montana var. lobata root pinus palustris leaf oenothera biennis flower citrus junos fruit yucca schidigera root quillaja saponaria bark melaleuca alternifolia leaf lonicera japonica flower echinacea angustifolia root jojoba oil tea tree oil lemon oil, cold pressed bergamot oil hydrolyzed soy protein (enzymatic; 2000 mw) hydrolyzed wheat protein (enzymatic; 3000 mw) hair keratin amino acids methylpropanediol dipropylene glycol 1,2-hexanediol butylene glycol ethylhexylglycerin dexpanthenol zinc chloride glyceryl monocaprylate climbazole piroctone olamine niacinamide citric acid monohydrate caffeine biotin menthol, unspecified form cetostearyl alcohol sodium chloride guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) pistacia lentiscus resin oil edetate disodium anhydrous 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:
⢠use 3-5ml at a time, once a day ⢠wet hair with warm water, lather, and rinse.
Package Label Principal Display Panel:
Image description