Arnica Wh Montana Nartex
Arnica Montana, Hamamelis Virginiana
Nartex Laboratorios Homeopaticos, S.a. De C.v.
Human Otc Drug
NDC 34666-401Arnica Wh Montana Nartex also known as Arnica Montana, Hamamelis Virginiana is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos, S.a. De C.v.'. National Drug Code (NDC) number for Arnica Wh Montana Nartex is 34666-401. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arnica Wh Montana Nartex drug includes Arnica Montana - 1 [hp_X]/g Hamamelis Virginiana Whole - 1 [hp_X]/g . The currest status of Arnica Wh Montana Nartex drug is Active.
Drug Information:
| Drug NDC: | 34666-401 |
| 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: | Arnica Wh Montana Nartex |
| 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, Hamamelis Virginiana |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nartex Laboratorios Homeopaticos, S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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 - 1 [hp_X]/g
HAMAMELIS VIRGINIANA WHOLE - 1 [hp_X]/g
|
| 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: | 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: | 19 May, 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. |
| 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: | Nartex Laboratorios Homeopaticos, S.A. de C.V.
|
| 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. |
| UPC: | 0844827001389
|
| UPC stands for Universal Product Code. |
| UNII: | O80TY208ZW
V663Q8TEFU
|
| 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 |
|---|
| 34666-401-01 | 1 TUBE in 1 CARTON (34666-401-01) / 74 g in 1 TUBE | 19 May, 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:
Purpose arnica montana tinc hpus*..........................anti-inflammatory/pain relief hamamelis virginiana tinc hpus*..........................anti-inflammatory/pain relief
Product Elements:
Arnica wh montana nartex arnica montana, hamamelis virginiana water alcohol arnica montana arnica montana hamamelis virginiana whole hamamelis virginiana whole carbomer homopolymer, unspecified type menthol sodium hydroxide
Indications and Usage:
Uses temporary relief for the symptoms of sore muscles, bruises and sprains. claims based on traditional homeopathic practice, not accepted medical evidence. the uses have not been evaluated by fda, and product has not been clinically tested.
Warnings:
Warnings for external use only. do not apply to wounds or damaged skin. apply over large areas of the body. when using this product avoid contact with eyes or mucous membranes. do not bandage tightly. stop use and ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days rash develops if pregnant or breast feeding, consult a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only. do not apply to wounds or damaged skin. apply over large areas of the body. when using this product avoid contact with eyes or mucous membranes. do not bandage tightly. stop use and ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days rash develops if pregnant or breast feeding, consult a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes or mucous membranes. do not bandage tightly.
Dosage and Administration:
Directions adults and children over 2 years of age: apply generously rubbing into affected area as needed. children 2 years of age: consult a physician.
Stop Use:
Stop use and ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days rash develops
Package Label Principal Display Panel:
New ndc 34666-401-01 arnica wh montana nartex gel homeopathic temporary relief for the symptoms of sore muscles, bruises and sprains. arnica & hamamelis claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. paraben free non-greasy with menthol as fragrance homeopathic absorbs quickly for external use only contains witch hazel hamamelis net wt. 2.6 oz (74 g) 1 2
Further Questions:
Questions or comments? informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm cst