Maetria Miracle Recipe Premiumshampoo
Salicylic Acid
J 1010 Co., Ltd.
Human Otc Drug
NDC 82934-401Maetria Miracle Recipe Premiumshampoo also known as Salicylic Acid is a human otc drug labeled by 'J 1010 Co., Ltd.'. National Drug Code (NDC) number for Maetria Miracle Recipe Premiumshampoo is 82934-401. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Maetria Miracle Recipe Premiumshampoo drug includes Salicylic Acid - 1 g/100mL . The currest status of Maetria Miracle Recipe Premiumshampoo drug is Active.
Drug Information:
| Drug NDC: | 82934-401 |
| 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: | Maetria Miracle Recipe Premiumshampoo |
| 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: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | J 1010 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: | SALICYLIC ACID - 1 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: | 13 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | J 1010 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: | 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 |
|---|
| 82934-401-01 | 1 mL in 1 BOTTLE, PUMP (82934-401-01) | 13 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 salicylic acid 0.2% â¦â¦â¦â¦â¦â¦.. anti dandruff
Product Elements:
Maetria miracle recipe premiumshampoo salicylic acid peg-120 methyl glucose dioleate lycium chinense fruit prunella vulgaris morinda citrifolia leaf angelica dahurica root lithospermum erythrorhizon root paeonia x suffruticosa root cornus officinalis fruit pea aceneuramic acid wine grape sodium c14-16 olefin sulfonate ethylhexylglycerin panthenol niacinamide pueraria montana var. lobata root alanine water phellinus linteus whole houttuynia cordata flowering top eclipta prostrata leaf sodium chloride green tea leaf ginkgo myrrh oil hydroxyacetophenone salicylic acid salicylic acid raspberry citric acid monohydrate biotin 1,2-hexanediol ecklonia cava menthol thuja occidentalis leaf sparassis crispa fruiting body perilla frutescens leaf vitex trifolia fruit polygala tenuifolia root angelica gigas root sodium sulfate tetradecene hexadecene (mixed isomers) caprylyl glycol coco-betaine glycerin propanediol polyquaternium-10 (1000 mpa.s at 2%) pentylene glycol butylene glycol allantoin pinus palustris leaf rubus coreanus fruit morus alba root reynoutria multiflora root lonicera japonica flower rehmannia glutinosa root resveratrol fragrance floral orc0902236 acetyl tetrapeptide-3 scutellaria baicalensis root caprylhydroxamic acid edetate disodium anhydrous xanthan gum sophora flavescens root paprika genistein
Indications and Usage:
Uses hair loss symptom relief shampoo cleanses the scalp of the hair and helps the healthy hair by supplying nutrients as the main ingredient
Warnings:
Warnings · stop use and consult a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching, due to direct sunlight when using or after using the product. · do not use in areas with open wounds. · keep out of reach of children. · when using the product, wash the eye immediately if it gets into the eye. · do not leave the product unwashed, as it may cause hair loss or bleaching if it is not rinsed with water. · keep it away from direct sunlight.
Do Not Use:
Warnings · stop use and consult a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching, due to direct sunlight when using or after using the product. · do not use in areas with open wounds. · keep out of reach of children. · when using the product, wash the eye immediately if it gets into the eye. · do not leave the product unwashed, as it may cause hair loss or bleaching if it is not rinsed with water. · keep it away from direct sunlight.
When Using:
Warnings when using the product, wash the eye immediately if it gets into the eye.
Dosage and Administration:
Directions after fully wetting hair with water, apply an appropriate amount on hair and scalp. fully lather and wash with lukewarm water.
Stop Use:
Warnings stop use and consult a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching, due to direct sunlight when using or after using the product.
Package Label Principal Display Panel:
Display panel j1010_label