NDC 72363-004 Banda-sil Gel Silver Wound Dressing

Argentum Metallucum

NDC Product Code 72363-004

NDC 72363-004-03

Package Description: 1 TUBE in 1 BOX > 21.5 g in 1 TUBE (72363-004-01)

NDC Product Information

Banda-sil Gel Silver Wound Dressing with NDC 72363-004 is a a human over the counter drug product labeled by Ag Essence Inc. The generic name of Banda-sil Gel Silver Wound Dressing is argentum metallucum. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Banda-sil Gel Silver Wound Dressing 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.


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.

  • ARGININE (UNII: 94ZLA3W45F)
  • WATER (UNII: 059QF0KO0R)
  • POLYQUATERNIUM-4 (1600 MPA.S AT 2%) (UNII: YE8J8372VI)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Ag Essence Inc
Labeler Code: 72363
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: 06-25-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-30-2023 What is the End Marketing Date?
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.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Banda-sil Gel Silver Wound Dressing Product Label Images

Banda-sil Gel Silver Wound Dressing 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

Dosage & 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.

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.

Inactive Ingredient

Complex Ag 21, Agua, Polycationic Polymers, Glycerin, L-Arginine

Indications & 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

Otc - Keep Out Of Reach Of Children

Warnings: For external use only. Keep out of reach of children.

Otc - Purpose

Topical AntisepticHomeopathic Medicine

Otc - Active Ingredient

Active: Argentum Metallcum (Metallic Silver 10X 20X 30X HPUS)

Banda-Sil Silver Wound Gel Box

Homeopathic DrugBanda-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

* Please review the disclaimer below.