Opsonat

Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top


Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-313
Opsonat also known as Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Opsonat is 59469-313. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Opsonat drug includes Bellis Perennis Whole - 1 [hp_X]/100mL Glechoma Hederacea Flowering Top - 1602 mg/100mL Goldenseal - 5 [hp_X]/100mL Gratiola Officinalis Whole - 4 [hp_X]/100mL Lachesis Muta Venom - 8 [hp_X]/100mL Lytta Vesicatoria - 4 [hp_X]/100mL Silver Nitrate - 6 [hp_X]/100mL Sulfuric Acid - 6 [hp_X]/100mL . The currest status of Opsonat drug is Active.

Drug Information:

Drug NDC: 59469-313
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: Opsonat
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: Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top
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: Solution/ Drops
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:BELLIS PERENNIS WHOLE - 1 [hp_X]/100mL
GLECHOMA HEDERACEA FLOWERING TOP - 1602 mg/100mL
GOLDENSEAL - 5 [hp_X]/100mL
GRATIOLA OFFICINALIS WHOLE - 4 [hp_X]/100mL
LACHESIS MUTA VENOM - 8 [hp_X]/100mL
LYTTA VESICATORIA - 4 [hp_X]/100mL
SILVER NITRATE - 6 [hp_X]/100mL
SULFURIC ACID - 6 [hp_X]/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 24 Jun, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 06 May, 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, 2024
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:2HU33I03UY
2458J91U39
ZW3Z11D0JV
BDD9991A36
VSW71SS07I
3Q034RO3BT
95IT3W8JZE
O40UQP6WCF
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
59469-313-101 BOTTLE, GLASS in 1 BOX (59469-313-10) / 50 mL in 1 BOTTLE, GLASS24 Jun, 2019N/ANo
59469-313-401 BOTTLE, GLASS in 1 BOX (59469-313-40) / 100 mL in 1 BOTTLE, GLASS24 Jun, 2019N/ANo
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.

Purpose:

For relief of minor mucous membrane inflammation, such as the mouth. 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.

Product Elements:

Opsonat silver nitrate, sulfuric acid, bellis perennis, lytta vesicatoria, gratiola officinalis, goldenseal, lachesis muta venom, and glechoma hederacea flowering top silver nitrate silver cation sulfuric acid sulfuric acid bellis perennis whole bellis perennis whole lytta vesicatoria lytta vesicatoria gratiola officinalis whole gratiola officinalis whole goldenseal goldenseal lachesis muta venom lachesis muta venom glechoma hederacea flowering top glechoma hederacea flowering top water alcohol

Indications and Usage:

Indications for relief of minor mucous membrane inflammation, such as the mouth. 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.

Warnings:

Warning 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:

Dosage unless otherwise prescribed, adults take 15-20 drops, 3 times per day. for pediatric dosages, consult your practitioner.

Package Label Principal Display Panel:

Principal display panel - 100 ml bottle box opsonat™ oral drops homeopathic medicine for relief of minor mucous membrane inflammation, such as the mouth 3.34 fl oz (100 ml) pekana ® principal display panel - 100 ml bottle box

Further Questions:

To report adverse events, contact bioresource at 321b blodgett street, cotati, ca 94931


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.