Arnica Recovery
Arnica Montana
Nartex Laboratorios Homeopaticos Sa De Cv
Human Otc Drug
NDC 34666-010Arnica Recovery also known as Arnica Montana is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos Sa De Cv'. National Drug Code (NDC) number for Arnica Recovery is 34666-010. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Arnica Recovery drug includes Arnica Montana - 6 [hp_C]/1 . The currest status of Arnica Recovery drug is Active.
Drug Information:
| Drug NDC: | 34666-010 |
| 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: | Arnica Recovery |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nartex Laboratorios Homeopaticos Sa De Cv |
| 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 - 6 [hp_C]/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 Jul, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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. |
| 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 SA DE CV
|
| 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: | O80TY208ZW
|
| 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 |
|---|
| 34666-010-12 | 12 TABLET in 1 BLISTER PACK (34666-010-12) | 01 Mar, 2018 | N/A | No |
| 34666-010-60 | 60 TABLET in 1 BLISTER PACK (34666-010-60) | 01 Jul, 2011 | 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:
Arnica montana.......6c hpus*..........anti-inflammatory *the letters "hpus" indicate that the components in this product are officially monographed in the homeopathic pharmacopoeia of the united states. c is a homeopathic dilution. see www.nartexlabsusa.com for more information. active ingredients are preparaed in accordance with the homeopathic pharmacopoeia of the united states, and are therefore non-toxic and have no known side effects.
Product Elements:
Arnica recovery arnica montana gelatin lactose magnesium stearate starch, potato talc arnica montana arnica montana none
Indications and Usage:
For the temporary relief of sore muscles bruises sprains as per homeopathic materia medica product uses are based on homeopathic materia medica. these "uses" have not been evaluated by teh food and drug administration. this product has not been clinically tested by nartex labs usa, inc.
Warnings:
Do not use if you have an allergy or hypersensitivity to the components of the formula.
Dosage and Administration:
Directions: adults and children 4 years of age and older: take 2 tablets every 6 hours, slowly dissolving in mouth children under 4 years of age: consult a physician
Stop Use:
Stop and ask a physician if: condition worsens if symptoms persist for more than 7 days or clear up and occur again within a few days rash develops
Description:
Distributed by: nartex labs usa, inc. 11711 memorial dr. #685 houston tx 77024 www.nartexlabsusa.com
Product claims are based on homeopathic materia medica. this product has not been clinically tested by nartex. keep carton. it contains important information. for you protection, this bottle has a seal around the neck. attention: do not use if hte neck seal is broken. this product is homeopathic. its claim and efficacy are based on homeopathic research and clinical experience. this product has not been evaluated for efficacy by fda with the same rules and procedures as those for other non-homeopathic drugs. for more information on homeopathy visit www.nartexlabsusa.com before using this product.
Package Label Principal Display Panel:
Ndc 34666-010-60 arnica recovery nartex for sore muscles and bruises* directions 2 tablets every 6 hours** homeopathic 60 tablets *based on homeopathic materia medica **see directions at the back. arnicatabletscarton
Further Questions:
Questions or comments? informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm cst