NDC 43742-1397 Celeragesic

Echinacea (angustifolia), Calendula Officinalis, Hamamelis Virginiana, Echinacea Purpurea, Bellis Perennis, Chamomilla, Hypericum Perforatum, Millefolium, Ledum Palustre, Arnica Montana, Bryonia (alba), Hepar Sulphuris Calcareum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Symphytum Officinale, Rhus Tox, Aconitum Napellus, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis

NDC Product Code 43742-1397

NDC CODE: 43742-1397

Proprietary Name: Celeragesic 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: Echinacea (angustifolia), Calendula Officinalis, Hamamelis Virginiana, Echinacea Purpurea, Bellis Perennis, Chamomilla, Hypericum Perforatum, Millefolium, Ledum Palustre, Arnica Montana, Bryonia (alba), Hepar Sulphuris Calcareum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Symphytum Officinale, Rhus Tox, Aconitum Napellus, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis 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, Inc.

NDC 43742-1397-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Celeragesic with NDC 43742-1397 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Celeragesic is echinacea (angustifolia), calendula officinalis, hamamelis virginiana, echinacea purpurea, bellis perennis, chamomilla, hypericum perforatum, millefolium, ledum palustre, arnica montana, bryonia (alba), hepar sulphuris calcareum, nadidum, pantothenic acid, sarcolacticum acidum, symphytum officinale, rhus tox, aconitum napellus, funiculus umbilicalis suis, glandula suprarenalis suis. The product's dosage form is gel and is administered via topical form.

Labeler Name: Deseret Biologicals, Inc.

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.

Celeragesic 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.

  • ECHINACEA ANGUSTIFOLIA 1 [hp_X]/g
  • CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/g
  • ECHINACEA PURPUREA 2 [hp_X]/g
  • BELLIS PERENNIS 2 [hp_X]/g
  • MATRICARIA RECUTITA 3 [hp_X]/g
  • HYPERICUM PERFORATUM 3 [hp_X]/g
  • ACHILLEA MILLEFOLIUM 3 [hp_X]/g
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 4 [hp_X]/g
  • ARNICA MONTANA 4 [hp_X]/g
  • BRYONIA ALBA ROOT 8 [hp_X]/g
  • CALCIUM SULFIDE 8 [hp_X]/g
  • NADIDE 8 [hp_X]/g
  • PANTOTHENIC ACID 8 [hp_X]/g
  • LACTIC ACID, L- 8 [hp_X]/g
  • COMFREY ROOT 8 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 8 [hp_X]/g
  • ACONITUM NAPELLUS 12 [hp_X]/g
  • SUS SCROFA UMBILICAL CORD 12 [hp_X]/g
  • SUS SCROFA ADRENAL GLAND 12 [hp_X]/g

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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO (UNII: 0E5AT8T16U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Deseret Biologicals, Inc.
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: 10-31-2018 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.

Celeragesic 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:

Echinacea (Angustifolia) 1X, Calendula Officinalis 1X, 6X, Hamamelis Virginiana 1X, 6X, Echinacea Purpurea 2X, Bellis Perennis 2X, 6X, Chamomilla 3X, Hypericum Perforatum 3X, 6X, Millefolium 3X, 6X, Arnica Montana 4X, 12X, 30X, 200X, Bryonia (Alba) 8X, Hepar Sulphuris Calcareum 8X, Nadidum 8X, Pantothenic Acid 8X, Prunus Cerasifera Flos 8X, Sarcolacticum Acidum 8X, Symphytum Officinale 8X, Rhus Tox 8X, 12X, 30X, Aconitum Napellus 12X, Funiculus Umbilicalis Suis 12X, Glandula Suprarenalis Suis 12X.

Homeopathic Indications:

For the temporary relief of muscular pain, joint pain, sports injuries and bruising.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

For the temporary relief of muscular pain, joint pain, sports injuries and bruising.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

For external use only.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.If pregnant or breast-feeding, ask 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply to the affected area as needed.

Inactive Ingredients:

Demineralized Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-33 (and) PEG-8 Dimethicone(and) PEG-14, Aloe Barbadensis Leaf Juice, Sodium Hydroxide Solution, Ethanol, Tocopherols [Vitamin E Oil], Edetate Disodium, Natural Plant Extract, Potassium Sorbate.

Questions:

Dist. By Deseret Biologicals, Inc.www.desbio.com469 W. Parkland DriveSandy, UT 84070

Package Label Display:

DESBIONDC 43742-1397-1CELERAGESICHomeopathic Gel for Management of Acute PainNET WT 2 OZ (57 g)

* Please review the disclaimer below.