NDC 34666-001 Arnica Montana Nartex

Arnica Montana, Hamamelis Virginiana

NDC Product Code 34666-001

NDC 34666-001-10

Package Description: 1 TUBE in 1 CARTON > 29.7 g in 1 TUBE

NDC 34666-001-20

Package Description: 1 TUBE in 1 CARTON > 99.79 g in 1 TUBE

NDC Product Information

Arnica Montana Nartex with NDC 34666-001 is a a human over the counter drug product labeled by Nartex Laboratorios Homeopaticos Sa De Cv. The generic name of Arnica Montana Nartex is arnica montana, hamamelis virginiana. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 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.


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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • LANOLIN (UNII: 7EV65EAW6H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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 Sa De Cv
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: 06-01-2007 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: 12-31-2021 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 Montana Nartex Product Label Images

Arnica 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 HPUSThe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the Untied States.

Purpose

Arnica montana TINC HPUS......................Anti-inflammatory/Pain relief


Hamamelis virginiana TINC HPUS.............Anti-inflammatory/Pain relief

Uses:

Temporary relief for the symptoms of sore muscles, bruises and sprains.

Warnings

For external use only.

Do Not

  • Apply to wounds or damaged skinapply over large areas of the body

When Using This Product

  • Avoid contact with eyes or mucous membranesdo 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 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.

Other Safety Information

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 neededchildren 2 years of age: consult a physician

Other Information

  • Store at room temperature

Inactive Ingredients

Glycerin, Lanolin wax, Paraffin wax, Sodium benzoate, Water, White petrolatum

Description

Active ingredients are prepared in accordance with the Homeopathic
Pharmacopoeia of the United States, and are therefore non-toxic and
have no known side effects.


Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by  Nartex.


Made in Mexico by:


NARTEX


Laboratorios Homeopaticos,


S.A. de C.V.


Calz. Lazaro Cardenas 708-770 Ote.


Col. Eduardo Guerra


Torreon, Coah. Mexico C.P. 27280


www.nartexlabs.com

* Please review the disclaimer below.