Arnica Montana 3x, 6x, 12x, 30x, 200x
Arnica Montana Root
Medinatura Inc
Human Otc Drug
NDC 62795-1112Arnica Montana 3x, 6x, 12x, 30x, 200x also known as Arnica Montana Root is a human otc drug labeled by 'Medinatura Inc'. National Drug Code (NDC) number for Arnica Montana 3x, 6x, 12x, 30x, 200x is 62795-1112. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Arnica Montana 3x, 6x, 12x, 30x, 200x drug includes Arnica Montana Root - 3 [hp_X]/1 . The currest status of Arnica Montana 3x, 6x, 12x, 30x, 200x drug is Active.
Drug Information:
| Drug NDC: | 62795-1112 |
| 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: | Arnica Montana 3x, 6x, 12x, 30x, 200x |
| 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: | Arnica Montana Root |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medinatura Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | ARNICA MONTANA ROOT - 3 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | UNAPPROVED HOMEOPATHIC |
| 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 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Feb, 2027 |
| 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. |
| Listing Expiration Date: | 06 May, 2026 |
| 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: | MediNatura 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: | MUE8Y11327
|
| 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 |
|---|
| 62795-1112-2 | 100 TABLET in 1 BOTTLE (62795-1112-2) | 01 Aug, 2016 | 28 Feb, 2027 | 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:
Indications ⢠symptoms of bruising ⢠pain
Product Elements:
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Indications and Usage:
Uses for the temporary relief of: ⢠symptoms of bruising ⢠pain
Warnings:
Warnings if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if symptoms persist or worsen, a health professional should be consulted. do not use if sensitivity to hendel arnica montana 3x, 6x, 12x, 30x, 200x or any of its ingredients exists. in case of accidental overdose, contact a poison control center immediately
Dosage and Administration:
Directions dosage: adults 18 and over : 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.
Package Label Principal Display Panel:
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