Banda-sil Gel Silver Wound Dressing
Argentum Metallucum
Ag Essence Inc
Human Otc Drug
NDC 72363-004Banda-sil Gel Silver Wound Dressing also known as Argentum Metallucum is a human otc drug labeled by 'Ag Essence Inc'. National Drug Code (NDC) number for Banda-sil Gel Silver Wound Dressing is 72363-004. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Banda-sil Gel Silver Wound Dressing drug includes Silver - 1 g/21.5g . The currest status of Banda-sil Gel Silver Wound Dressing drug is Active.
Drug Information:
| Drug NDC: | 72363-004 |
| 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: | Banda-sil Gel Silver Wound Dressing |
| 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: | Argentum Metallucum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ag Essence Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | SILVER - 1 g/21.5g
|
| 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: | 25 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Nov, 2023 |
| 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: | 25 Dec, 2025 |
| 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: | AG Essence Inc
|
| 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: | 3M4G523W1G
|
| 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 |
|---|
| 72363-004-03 | 1 TUBE in 1 BOX (72363-004-03) / 21.5 g in 1 TUBE (72363-004-01) | 30 Jun, 2021 | 30 Nov, 2023 | 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. |
Purpose:
Topical antiseptic homeopathic medicine
Product Elements:
Banda-sil gel silver wound dressing argentum metallucum silver silver arginine water polyquaternium-4 (1600 mpa.s at 2%) glycerin
Indications and Usage:
Indications: for relief of these symptoms due to minor wounds, burns, scrapes, ulcerations or minor infections. burning stinging itching redness minor pain minor inflamation
Warnings:
Warnings: for external use only. keep out of reach of children. consult a doctor if condition worsens or does not improve in seven (7) days. ask a doctor for before use if you have deep or puncture wounds serious blleding or serious burns.
Dosage and Administration:
Directions: clean wound area of dirt and debris. apply a layer of hydrogel to the affected area. cover with a sterile gauze or appropriate secondary dressing and secure in place. banda-sil silver wound gel may be left in place for up to 3 days. change more frequently depending on wound drainage. indications for use: for relief of symptoms due to wounds, burns, scrapes, ulcerations or minor infections. disclaimer: these statements have not been evaluated by the fda. this product is not intended to diagnose, treat, cure or prevent any disease.
Package Label Principal Display Panel:
Banda-sil silver wound gel box homeopathic drug banda-sil silver wound gel ingredients: active: argentum metallicum 10x, 20x and 30x hpus inactive: ag21 complex, aqua, polycationic polymers, glycerin, l-arginine purpose gel wound dressing homeopathic medicine warnings: for external use only keep out of reach of children banda-sil gel box