NDC 34666-401 Arnica Wh Montana Nartex

Arnica Montana, Hamamelis Virginiana

NDC Product Code 34666-401

NDC CODE: 34666-401

Proprietary Name: Arnica Wh Montana Nartex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Arnica Montana, Hamamelis Virginiana What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 34666 - Nartex Laboratorios Homeopaticos, S.a. De C.v.

NDC 34666-401-01

Package Description: 1 TUBE in 1 CARTON > 74 g in 1 TUBE

NDC Product Information

Arnica Wh Montana Nartex with NDC 34666-401 is a a human over the counter drug product labeled by Nartex Laboratorios Homeopaticos, S.a. De C.v.. The generic name of Arnica Wh Montana Nartex is arnica montana, hamamelis virginiana. The product's dosage form is gel and is administered via topical form.

Labeler Name: Nartex Laboratorios Homeopaticos, S.a. De C.v.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Arnica Wh Montana Nartex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ARNICA MONTANA 1 [hp_X]/g
  • HAMAMELIS VIRGINIANA WHOLE 1 [hp_X]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • MENTHOL (UNII: L7T10EIP3A)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nartex Laboratorios Homeopaticos, S.a. De C.v.
Labeler Code: 34666
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-19-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Arnica Wh Montana Nartex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Each dose contains equal parts of:Arnica montana TINC HPUS*Hamamelis virginiana TINC HPUS**THe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC is an homeopathic dilution. See www.nartexlabsusa.com for more information.

Purpose

Arnica montana TINC HPUS*..........................Anti-inflammatory/Pain reliefHamamelis virginiana TINC HPUS*..........................Anti-inflammatory/Pain relief

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

For external use only.

Otc - Do Not Use

  • Do notapply to wounds or damaged skin.apply over large areas of the body.

Otc - When Using

  • When using this productavoid contact with eyes or mucous membranes.do not bandage tightly.

Otc - Stop Use

  • Stop use and ask a doctor ifsymptoms persist for more than 7 days or clear up and occur again within a few daysrash develops

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, consult a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information

  • Do not use if the tube seal is broken or missing.store at room temperature.

Inactive Ingredients

Alcohol, Carbomer, Menthol (fragrance), Purified water, Sodium hydroxide

* Please review the disclaimer below.