NDC 43742-1509 Gum Therapy

Calendula Officinalis, Kali Phosphoricum, Natrum Muriaticum, Arnica Montana, Agave Americana, Cistus Canadensis, Kreosotum, Myrrha, Calcarea Fluorica, Aconitum Napellus, Bismuthum Subnitricum, Sepia, Hepar Sulphuris Calcareum, Mercurius Vivus

NDC Product Code 43742-1509

NDC Code: 43742-1509

Proprietary Name: Gum Therapy 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.

Non-Proprietary Name: Calendula Officinalis, Kali Phosphoricum, Natrum Muriaticum, Arnica Montana, Agave Americana, Cistus Canadensis, Kreosotum, Myrrha, Calcarea Fluorica, Aconitum Napellus, Bismuthum Subnitricum, Sepia, Hepar Sulphuris Calcareum, Mercurius Vivus 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.

NDC Code Structure

  • 43742 - Deseret Biologicals

NDC 43742-1509-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Gum Therapy with NDC 43742-1509 is a a human over the counter drug product labeled by Deseret Biologicals. The generic name of Gum Therapy is calendula officinalis, kali phosphoricum, natrum muriaticum, arnica montana, agave americana, cistus canadensis, kreosotum, myrrha, calcarea fluorica, aconitum napellus, bismuthum subnitricum, sepia, hepar sulphuris calcareum, mercurius vivus. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Deseret Biologicals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Gum Therapy 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.

  • CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL
  • DIBASIC POTASSIUM PHOSPHATE 3 [hp_X]/mL
  • SODIUM CHLORIDE 3 [hp_X]/mL
  • ARNICA MONTANA 6 [hp_X]/mL
  • AGAVE AMERICANA LEAF 6 [hp_X]/mL
  • HELIANTHEMUM CANADENSE 6 [hp_X]/mL
  • WOOD CREOSOTE 6 [hp_X]/mL
  • MYRRH 8 [hp_X]/mL
  • CALCIUM FLUORIDE 12 [hp_X]/mL
  • ACONITUM NAPELLUS 12 [hp_X]/mL
  • BISMUTH SUBNITRATE 12 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 12 [hp_X]/mL
  • CALCIUM SULFIDE 12 [hp_X]/mL
  • MERCURY 12 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.

Labeler Name: Deseret Biologicals
Labeler Code: 43742
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: 08-20-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gum Therapy Product Label Images

Gum Therapy 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

Active Ingredients:

Calendula Officinalis 1X, 6X, 12X, 30X, Kali Phosphoricum 3X, Natrum Muriaticum 3X, Arnica Montana 3X, 6X, 12X, 30X, Agave Americana 6X, Cistus Canadensis 6X, Kreosotum 6X, Myrrha 6X, Calcarea Fluorica 8X, Aconitum Napellus 12X, Bismuthum Subnitricum 12X, Sepia 12X, Hepar Sulphuris Calcareum 12X, 18X, 30X, Mercurius Vivus 12X, 18X, 30X.

Homeopathic Indications:

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

For temporary relief of symptoms related to gingivitis, inflamed and bleeding gums and minor pain.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, Contact physician or Poison Control Center right away.If pregnant or breast-feeding, seek advice of a health professional before use.Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Questions:

Dist. By: Deseret Biologicals, Inc.469 W. Parkland DriveSandy, UT 84070 www.desbio.com

Package Label Display:

DESBIONDC 43742-1509-1HOMEOPATHICGUMTHERAPY1 FL OZ (30 ml)

* Please review the disclaimer below.