Arnica Montana Nartex

Nartex Laboratorios Homeopaticos Sa De Cv
Human Otc Drug
NDC 34666-281

Arnica Montana Nartex is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos Sa De Cv'. National Drug Code (NDC) number for Arnica Montana Nartex is 34666-281. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arnica Montana Nartex drug includes Arnica Montana - 1 [hp_X]/1 Bellis Perennis - 3 [hp_X]/1 Calendula Officinalis Whole - 1 [hp_X]/1 Hamamelis Virginiana Whole - 3 [hp_X]/1 Matricaria Chamomilla - 3 [hp_X]/1 . The currest status of Arnica Montana Nartex drug is Active.

Drug Information:

Drug NDC:	34666-281
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 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 Nartex
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:	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]/1 BELLIS PERENNIS - 3 [hp_X]/1 CALENDULA OFFICINALIS WHOLE - 1 [hp_X]/1 HAMAMELIS VIRGINIANA WHOLE - 3 [hp_X]/1 MATRICARIA CHAMOMILLA - 3 [hp_X]/1
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:	25 Jan, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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.
UPC:	0844827000979
UPC stands for Universal Product Code.
UNII:	O80TY208ZW 2HU33I03UY PFR03EBU0H V663Q8TEFU G0R4UBI2ZZ
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
34666-281-30	1 GEL in 1 BOTTLE, DISPENSING (34666-281-30)	25 Jan, 2019	N/A	No
34666-281-60	1 GEL in 1 BOTTLE, DISPENSING (34666-281-60)	25 Jan, 2019	N/A	No
34666-281-90	1 GEL in 1 BOTTLE, DISPENSING (34666-281-90)	25 Jan, 2019	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.

Other medicines with the same generic name

Arnica Montana Nartex

Gel
Nartex Laboratorios Homeopaticos SA DE CV
NDC: 34666-281

Purpose:

Purpose arnica tinc hpus*...............anti-inflammatory/pain relief bellis 3x hpus*.....................sprains and bruises calendula hpus*..................pain relief chamomila 3x hpus*..........anti-inflammatory hamamelis 3x hpus*............anti-inflammatory/pain relief *the letters hpus indicate that the components in this product are officially monographed in the homeopathic pharmacopoeia of the united states. tinc and x are homeopathic dilutions. see www.nartexlabsusa.com for more information.

Product Elements:

Arnica montana nartex arnica montana nartex arnica montana arnica montana anhydrous citric acid glycerin water bellis perennis bellis perennis calendula officinalis whole calendula officinalis whole matricaria chamomilla matricaria chamomilla hamamelis virginiana whole hamamelis virginiana whole aloe vera leaf menthol methylparaben sodium propylparaben sodium xanthan gum

Indications and Usage:

Uses for the temporary relief of: sore muscles bruises sprains minor burns insect bites indications are based on homeopathic materia medica, not clnical tests.

Warnings:

Warnings for external use only

Do Not Use:

Warnings for external use only

When Using:

When using this product avoid contact with eyes or mucous membranes do not bandage tightly or use with a heating pad

Dosage and Administration:

Directions adults and children over 4 years of age: apply and gently massage the affected area every 4 hours.

Stop Use:

Stop use and ask doctor if: symptoms persis for more than 7 days or clear up and occur again within a few days rash develops

Package Label Principal Display Panel:

Homeopathic arnica montana nartex roll-on gel for the temporary relief of: sore muscles, bruises, sprains, minor burns and insect bites. net wt. 2.11 oz (60 g) arnica roll on (60g)

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.