Guna-dermo Solution/ Drops
NDC 17089-295

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 17089-295?
  4. Guna-dermo Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Guna-dermo (aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur -) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This medication is typically used as a increased lymphocyte activation [pe]. It is supplied as a solution/ drops for oral administration. This product entry covers the primary NDC 17089-295 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-295
Proprietary Name:
Guna-dermo
Non-Proprietary Name: [1]
Aldesleukin - Arsenic Trioxide - Atropa Belladonna - Canakinumab - Echinacea Angustifolia - Graphite - Melatonin - Plantago Major - Solanum Dulcamara Flower - Sulfur -
Substance Name: [2]
Aldesleukin; Arsenic Trioxide; Atropa Belladonna; Canakinumab; Echinacea Angustifolia; Graphite; Melatonin; Plantago Major; Solanum Dulcamara Flower; Sulfur
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Guna Spa
Labeler Code:
17089
Product Label ID:
8bf717eb-fe46-4066-b124-eb715ffc1542
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-23-2006
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 17089-295?

The NDC code 17089-295 is assigned by the FDA to the product Guna-dermo. It is commonly known by its generic name, aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur -. This pharmaceutical product is labeled by Guna Spa and is currently categorized as listed product. The medication is a solution/ drops administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 17089-295-18. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Take 15 minutes before mealsAdults and children 12 years and older    20 drops in a little water, 2 times per dayChildren  between 12 years and 6 years of age    10 drops in a little water, 2 times per dayChildren under 6 years     5 drops in a glass of water, 2 times per day

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ALDESLEUKIN 4 [hp_C]/30mL - a recombinant human IL-2, marketed for the treatment of metastatic renal cell carcinoma; BAY 50-4798 is a variant
  • ARSENIC TRIOXIDE 6 [hp_C]/30mL - An inorganic compound with the chemical formula As2O3 that is used for the treatment of ACUTE PROMYELOCYTIC LEUKEMIA in patients who have relapsed from, or are resistant to, conventional drug therapy.
  • ATROPA BELLADONNA 6 [hp_C]/30mL - A plant species of the genus ATROPA, family SOLANACEAE that contains ATROPINE; SCOPOLAMINE; BELLADONNA ALKALOIDS and other SOLANACEOUS ALKALOIDS. Some species in this genus are called deadly nightshade which is also a common name for SOLANUM.
  • CANAKINUMAB 7 [hp_C]/30mL - a human anti-interleukin-1beta monoclonal antibody for treatment of cryopyrin-associated periodic syndrome
  • ECHINACEA ANGUSTIFOLIA 6 [hp_C]/30mL - A genus of perennial herbs used topically and internally. It contains echinacoside, GLYCOSIDES; INULIN; isobutyl amides, resin, and SESQUITERPENES.
  • GRAPHITE 6 [hp_C]/30mL - An allotropic form of carbon that is used in pencils, as a lubricant, and in matches and explosives. It is obtained by mining and its dust can cause lung irritation.
  • MELATONIN 4 [hp_C]/30mL - A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
  • PLANTAGO MAJOR 4 [hp_C]/30mL
  • SOLANUM DULCAMARA FLOWER 6 [hp_C]/30mL
  • SULFUR 6 [hp_C]/30mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".