Zeel
Arnica Montana Root, Toxicodendron Pubescens Leaf, Solanum Dulcamara Top, Comfrey Root, Sulfur, Sanguinaria Canadensis Root, Sus Scrofa Cartilage, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Sus Scrofa Placenta, .alpha.-lipoic Acid, Coenzyme A, Nadide And Sodium Diethyl Oxalacetate
Medinatura
Human Prescription Drug
NDC 50114-7030Zeel also known as Arnica Montana Root, Toxicodendron Pubescens Leaf, Solanum Dulcamara Top, Comfrey Root, Sulfur, Sanguinaria Canadensis Root, Sus Scrofa Cartilage, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Sus Scrofa Placenta, .alpha.-lipoic Acid, Coenzyme A, Nadide And Sodium Diethyl Oxalacetate is a human prescription drug labeled by 'Medinatura'. National Drug Code (NDC) number for Zeel is 50114-7030. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Zeel drug includes .alpha.-lipoic Acid - 8 [hp_X]/2mL Arnica Montana Root - 4 [hp_X]/2mL Coenzyme A - 8 [hp_X]/2mL Comfrey Root - 6 [hp_X]/2mL Nadide - 8 [hp_X]/2mL Sanguinaria Canadensis Root - 4 [hp_X]/2mL Sodium Diethyl Oxalacetate - 8 [hp_X]/2mL Solanum Dulcamara Top - 3 [hp_X]/2mL Sulfur - 6 [hp_X]/2mL Sus Scrofa Cartilage - 6 [hp_X]/2mL and more. The currest status of Zeel drug is Active.
Drug Information:
| Drug NDC: | 50114-7030 |
| 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: | Zeel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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 Root, Toxicodendron Pubescens Leaf, Solanum Dulcamara Top, Comfrey Root, Sulfur, Sanguinaria Canadensis Root, Sus Scrofa Cartilage, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Sus Scrofa Placenta, .alpha.-lipoic Acid, Coenzyme A, Nadide And Sodium Diethyl Oxalacetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medinatura |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | .ALPHA.-LIPOIC ACID - 8 [hp_X]/2mL
ARNICA MONTANA ROOT - 4 [hp_X]/2mL
COENZYME A - 8 [hp_X]/2mL
COMFREY ROOT - 6 [hp_X]/2mL
NADIDE - 8 [hp_X]/2mL
SANGUINARIA CANADENSIS ROOT - 4 [hp_X]/2mL
SODIUM DIETHYL OXALACETATE - 8 [hp_X]/2mL
SOLANUM DULCAMARA TOP - 3 [hp_X]/2mL
SULFUR - 6 [hp_X]/2mL
SUS SCROFA CARTILAGE - 6 [hp_X]/2mL
Load more...SUS SCROFA EMBRYO - 6 [hp_X]/2mL
SUS SCROFA PLACENTA - 6 [hp_X]/2mL
SUS SCROFA UMBILICAL CORD - 6 [hp_X]/2mL
TOXICODENDRON PUBESCENS LEAF - 2 [hp_X]/2mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRA-ARTICULAR
INTRADERMAL
INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | 31 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2024 |
| 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: | 01 Jan, 2026 |
| 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: | MediNatura
|
| 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: | 73Y7P0K73Y
MUE8Y11327
SAA04E81UX
M9VVZ08EKQ
0U46U6E8UK
N9288CD508
6CA025Y4FG
KPS1B1162N
70FD1KFU70
73ECW5WG2F
Load more...9928MC12VO
C8CV8867O8
118OYG6W3H
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 |
|---|
| 50114-7030-1 | 10 AMPULE in 1 CARTON (50114-7030-1) / 2 mL in 1 AMPULE | 31 Jul, 2014 | 31 Dec, 2024 | No |
| 50114-7030-2 | 3 AMPULE in 1 CARTON (50114-7030-2) / 2 mL in 1 AMPULE | 31 Jul, 2014 | 31 Dec, 2024 | 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. |
Product Elements:
Zeel arnica montana root, toxicodendron pubescens leaf, solanum dulcamara top, comfrey root, sulfur, sanguinaria canadensis root, sus scrofa cartilage, sus scrofa embryo, sus scrofa umbilical cord, sus scrofa placenta, .alpha.-lipoic acid, coenzyme a, nadide and sodium diethyl oxalacetate arnica montana root arnica montana root toxicodendron pubescens leaf toxicodendron pubescens leaf solanum dulcamara top solanum dulcamara top comfrey root comfrey root sulfur sulfur sanguinaria canadensis root sanguinaria canadensis root sus scrofa cartilage sus scrofa cartilage sus scrofa embryo sus scrofa embryo sus scrofa umbilical cord sus scrofa umbilical cord sus scrofa placenta sus scrofa placenta .alpha.-lipoic acid .alpha.-lipoic acid coenzyme a coenzyme a nadide nadide sodium diethyl oxalacetate diethyl oxalacetate sodium chloride water
Indications and Usage:
Indications and usage treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases zeel® injection solution is a homeopathic drug product indicated for the treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness. co-administration therapy with traumeel® injection solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system. zeel® injection solution is a homeopathic drug product indicated, in combination with traumeel® injection solution, for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.
Warnings and Cautions:
Warnings and precautions none
Dosage and Administration:
Dosage and administration general considerations the dosage schedules listed below can be used as a general guide for the administration of zeel ® injection solution. if co-administration with a local anesthetic is desired, zeel ® injection solution may be mixed with lidocaine or similar agents at the discretion of the physician. zeel ® injection solution may be administered s.c., i.d., i.m., i.a. or i.v. ⢠the interval between injections is left to the discretion of the hcp, but should not exceed 1 ampulein 24 hours. ⢠parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. draw up the contents of the ampule into the syringe. discard half or one third of the contents, depending on the required dosage, before administering ⢠only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should admini
Read more...ster the product. standard dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness. adults and children 12 years and older: 1 ampule 1 to 3 times per 7 days children 6 to 11 years: 2/3 of an ampule 1 to 3 times per 7 days acute dosage - for the treatment of arthrosis/osteoarthritis and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness. adults and children 12 years and older: 1 ampule daily, and then continue with standard dosage children 6 to 11 years: 2/3 of an ampule daily, and then continue with standard dosage co-administration therapy with traumeel® injection solution - for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness. in the treatment of musculoskeletal conditions, if co-administration with another homeopathic medicinal product is desired, zeel ® injection solution may be mixed in a ratio of 1:1 with traumeel ® injection solution. for convenience, the daily dose of zeel ® injection solution may be administered at the same time as a traumeel ® injection solution, according to the dosing recommendations for each medication.
Dosage Forms and Strength:
Dosage one ampule containing 2.0 ml each containing the active ingredients in the strengths listed under description.
Contraindications:
Contraindications zeel® injection solution is contraindicated in patients with known hypersensitivity to zeel® or any of its ingredients.
Adverse Reactions:
Adversere reactions post-marketing experience ⢠the following adverse events have been identified during post-marketing use of zeel ® injection solution. because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ⢠adverse event rates observed in monotherapy use of zeel ® injection solution: allergic (hypersensitivity) skin reactions may occur in isolated cases. â¢adverse event rates observed in monotherapy use of traumeel ® injection solution: allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases. to report suspected adverse reactions,contact medinatura. at 1.844.633.4628 or info@medinatura.com or fda at 1-800-fda-1088 or www.fda.gov/medwatch
Overdosage:
Overdosage no negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.
Description:
Description ingredient name potency quantity final dilution a-lipoicum acidum 8x 2.0 μl 10.99x arnica montana, radix 4x 200.0 μl 5.00x cartilago suis 6x 2.0 μl 9.00x coenzyme a 8x 2.0 μl 10.99x dulcamara 3x 10.0 μl 5.30x embryo totalis suis 6x 2.0 μl 9.00x funiculus umbilicalis suis 6x 2.0 μl 9.00x nadidum 8x 2.0 μl 10.99x natrum oxalaceticum 8x 2.0 μl 10.99x placenta suis 6x 2.0 μl 9.00x rhus toxicodendron 2x 10.0 μl 4.30x sanguinaria canadensis 4x 3.0 μl 6.82x sulphur 6x 3.6 μl 8.74x symphytum officinale 6x 10.0 μl 8.30
Clinical Pharmacology:
Clinical pharmacology mechanism of action the exact mechanism of zeel ® injection solution is not fully understood. pharmacodynamics not applicable for homeopathic medicinal products.
Package Label Principal Display Panel:
Zeel 2.0 ml injection.jpg