NDC 59469-309 Itires

Arnica Montana Root, Calcium Fluoride, Calcium Iodide, Clematis Recta Flowering Top, Scrophularia Nodosa, Conium Maculatum Flowering Top, Horse Chestnut, And Hedera Helix Flowering Twig

NDC Product Code 59469-309

NDC Code: 59469-309

Proprietary Name: Itires 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 Root, Calcium Fluoride, Calcium Iodide, Clematis Recta Flowering Top, Scrophularia Nodosa, Conium Maculatum Flowering Top, Horse Chestnut, And Hedera Helix Flowering Twig 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

NDC 59469-309-30

Package Description: 1 TUBE in 1 BOX > 30 g in 1 TUBE

NDC 59469-309-35

Package Description: 1 TUBE in 1 BOX > 35 g in 1 TUBE

NDC Product Information

Itires with NDC 59469-309 is a a human over the counter drug product labeled by Pekana Naturheilmittel Gmbh. The generic name of Itires is arnica montana root, calcium fluoride, calcium iodide, clematis recta flowering top, scrophularia nodosa, conium maculatum flowering top, horse chestnut, and hedera helix flowering twig. The product's dosage form is ointment and is administered via cutaneous form.

Labeler Name: Pekana Naturheilmittel Gmbh

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Itires 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 ROOT 8 [hp_X]/35g
  • CALCIUM FLUORIDE 8 [hp_X]/35g
  • CALCIUM IODIDE 6 [hp_X]/35g
  • CLEMATIS RECTA FLOWERING TOP 4 [hp_X]/35g
  • SCROPHULARIA NODOSA 2 [hp_X]/35g
  • CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/35g
  • HORSE CHESTNUT 4 [hp_X]/35g
  • HEDERA HELIX FLOWERING TWIG 6 [hp_X]/35g

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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SPERMACETI (UNII: P86KHA8V3K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

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

  • Cutaneous - Administration to the skin.

Product Labeler Information

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

Labeler Name: Pekana Naturheilmittel Gmbh
Labeler Code: 59469
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: 06-24-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Itires 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

Otc - Active Ingredient

Active ingredients:Aesculus hippocastanum4XArnica montana8XCalcium fluoratum8XCalcium jodatum6XClematis recta4XConium maculatum6XHedera helix6XScrophularia nodosa2X

Inactive Ingredients

Purified water, cetyl alcohol, cetylstearyl alcohol, glycerol, synthetic cetaceum, triglycerides. Selected ingredients prepared by spagyric processes.

Otc - Purpose

Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into affected area. For external use only. Do not use on open wounds!

Otc - Ask Doctor

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Storage And Handling

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

Otc - Questions

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

Other

Distributed by:BioResource Inc.Cotati, CA 94931Manufactured by:PEKANA® GmbHD-88353 Kisslegg

* Please review the disclaimer below.