Zellulisan

Horse Chestnut, Arnica Montana, Betula Pendula Leaf, Hedera Helix Flowering Twig, Ledum Palustre Twig, Melilotus Officinalis Top, Toxicodendron Pubescens Leaf, And Sulfur

Pekana-naturheilmittel Gmbh
Human Otc Drug
NDC 59469-038

Zellulisan also known as Horse Chestnut, Arnica Montana, Betula Pendula Leaf, Hedera Helix Flowering Twig, Ledum Palustre Twig, Melilotus Officinalis Top, Toxicodendron Pubescens Leaf, And Sulfur is a human otc drug labeled by 'Pekana-naturheilmittel Gmbh'. National Drug Code (NDC) number for Zellulisan is 59469-038. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Zellulisan drug includes Arnica Montana Whole - 8 [hp_X]/35g Betula Pendula Leaf - 8 [hp_X]/35g Hedera Helix Flowering Twig - 6 [hp_X]/35g Horse Chestnut - 4 [hp_X]/35g Melilotus Officinalis Top - 4 [hp_X]/35g Rhododendron Tomentosum Leafy Twig - 3 [hp_X]/35g Sulfur - 15 [hp_X]/35g Toxicodendron Pubescens Leaf - 8 [hp_X]/35g . The currest status of Zellulisan drug is Active.

Drug Information:

Drug NDC:	59469-038
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:	Zellulisan
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:	Horse Chestnut, Arnica Montana, Betula Pendula Leaf, Hedera Helix Flowering Twig, Ledum Palustre Twig, Melilotus Officinalis Top, Toxicodendron Pubescens Leaf, And Sulfur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Pekana-naturheilmittel Gmbh
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
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 WHOLE - 8 [hp_X]/35g BETULA PENDULA LEAF - 8 [hp_X]/35g HEDERA HELIX FLOWERING TWIG - 6 [hp_X]/35g HORSE CHESTNUT - 4 [hp_X]/35g MELILOTUS OFFICINALIS TOP - 4 [hp_X]/35g RHODODENDRON TOMENTOSUM LEAFY TWIG - 3 [hp_X]/35g SULFUR - 15 [hp_X]/35g TOXICODENDRON PUBESCENS LEAF - 8 [hp_X]/35g
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:	20 Feb, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 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:	Pekana-Naturheilmittel GmbH
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 5HW39H9KDH 3D10KUA6BM 3C18L6RJAZ GM6P02J2DX 877L01IZ0P 70FD1KFU70 6IO182RP7A
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
59469-038-35	1 TUBE in 1 CARTON (59469-038-35) / 35 g in 1 TUBE	20 Feb, 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.

Other medicines with the same generic name

Zellulisan

Horse Chestnut & more..

Ointment
Pekana-Naturheilmittel GmbH
NDC: 59469-038

Purpose:

For relief of minor tendinitis and inflammation

Product Elements:

Zellulisan horse chestnut, arnica montana, betula pendula leaf, hedera helix flowering twig, ledum palustre twig, melilotus officinalis top, toxicodendron pubescens leaf, and sulfur horse chestnut horse chestnut arnica montana whole arnica montana whole betula pendula leaf betula pendula leaf hedera helix flowering twig hedera helix flowering twig rhododendron tomentosum leafy twig rhododendron tomentosum leafy twig melilotus officinalis top melilotus officinalis top toxicodendron pubescens leaf toxicodendron pubescens leaf sulfur sulfur water cetostearyl alcohol glycerin medium-chain triglycerides cetyl esters wax

Indications and Usage:

Uses application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. these "uses" have not been evaluated by the food and drug administration. with severe forms of this disease, a clinically proven therapy is indicated. for relief of minor tendinitis and inflammation

Warnings:

Warnings for external use only. do not use on open wounds! 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. keep out of the reach of children.

Dosage and Administration:

Directions unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.

Package Label Principal Display Panel:

Principal display panel - 35 g tube carton pekana Â® zellulisanâ¢ homeopathic ointment for relief of minor tendinitis and inflammation 1.2 oz 35 g principal display panel - 35 g tube carton

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.