NDC 17089-295 Guna-dermo
Aldesleukin - Arsenic Trioxide - Atropa Belladonna - Canakinumab - Echinacea Angustifolia ...

Product Information

What is NDC 17089-295?

The NDC code 17089-295 is assigned by the FDA to the product Guna-dermo which is a human over the counter drug product labeled by Guna Spa. The generic name of Guna-dermo is aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur -. The product's dosage form is solution/ drops and is administered via oral form. The product is distributed in a single package with assigned NDC code 17089-295-18 1 bottle, dropper in 1 box / 30 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code17089-295
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Guna-dermo
Non-Proprietary Name 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.
Aldesleukin - Arsenic Trioxide - Atropa Belladonna - Canakinumab - Echinacea Angustifolia - Graphite - Melatonin - Plantago Major - Solanum Dulcamara Flower - Sulfur -
Product Type 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.
Human Otc Drug
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Guna Spa
Labeler Code17089
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-23-2006
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Guna-dermo?


Product Packages

NDC Code 17089-295-18

Package Description: 1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER

Product Details

What are Guna-dermo Active Ingredients?

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
  • 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
  • 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.

Guna-dermo Active Ingredients UNII Codes

Guna-dermo Inactive Ingredients 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.

Pharmacologic Class(es)

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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Guna-dermo Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients/Purpose



ARSENICUM ALBUM        6C    SKIN BLISTERS
BELLADONNA        6C    SWELLING
DULCAMARA        6C    MUSCLE SORENESS
ECHINACEA ANGUSTIFOLIA    6C    ANTI-INFECTION
GRAPHITES        6C    SKIN INFLAMMATION
INTERLEUKIN 1 BETA    7C    IMMUNE STRENGTHENING
INTERLEUKIN 2        4C    IMMUNE STRENGTHENING
MELATONIN        4C    HORMONAL SUPPORT
PLANTAGO MAJOR        4C    DETOXIFICATION
SULPHUR            6C    SENSITIVE SKIN


Uses



For the temporary relief of symptoms of general skin irritation and rashes such as: itching, dryness, hypersensitivity


Warnings



Stop use and ask doctor if symptoms of itching, dryness or hypersensitivity worsen or persist more than 5 days

Keep this and all medicines out of reach of children


Pregnancy



If pregnant or breast-feeding ask a doctor before use


Directions



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


Questions



Questions?: [email protected], tel. (484) 223-3500


* Please review the disclaimer below.