Speedgel Rx
Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale
Gensco Laboratories, Llc
Human Prescription Drug
NDC 35781-0210Speedgel Rx also known as Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale is a human prescription drug labeled by 'Gensco Laboratories, Llc'. National Drug Code (NDC) number for Speedgel Rx is 35781-0210. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Speedgel Rx drug includes Achillea Millefolium - 1 [hp_X]/30mL Aconitum Napellus - 3 [hp_X]/30mL Arnica Montana - 1 [hp_X]/30mL Atropa Belladonna - 3 [hp_X]/30mL Bellis Perennis - 1 [hp_X]/30mL Calendula Officinalis Flowering Top - 1 [hp_X]/30mL Chamomile - 1 [hp_X]/30mL Colchicine - 3 [hp_X]/30mL Comfrey Root - 3 [hp_X]/30mL Echinacea Angustifolia - 1 [hp_X]/30mL and more. The currest status of Speedgel Rx drug is Active.
Drug Information:
| Drug NDC: | 35781-0210 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Speedgel Rx |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gensco Laboratories, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACHILLEA MILLEFOLIUM - 1 [hp_X]/30mL
ACONITUM NAPELLUS - 3 [hp_X]/30mL
ARNICA MONTANA - 1 [hp_X]/30mL
ATROPA BELLADONNA - 3 [hp_X]/30mL
BELLIS PERENNIS - 1 [hp_X]/30mL
CALENDULA OFFICINALIS FLOWERING TOP - 1 [hp_X]/30mL
CHAMOMILE - 1 [hp_X]/30mL
COLCHICINE - 3 [hp_X]/30mL
COMFREY ROOT - 3 [hp_X]/30mL
ECHINACEA ANGUSTIFOLIA - 1 [hp_X]/30mL
Load more...ECHINACEA PURPUREA - 1 [hp_X]/30mL
GINGER - 1 [hp_X]/30mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 1 [hp_X]/30mL
HYPERICUM OIL - 1 [hp_X]/30mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TRANSDERMAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Dec, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Dec, 2025 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Gensco Laboratories, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000182141
N0000000239
N0000193949
M0000713
N0000185375
N0000185371
N0000175629
N0000184306
M0000728
M0006342
M0016962
M0008672
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 2FXJ6SW4PK
U0NQ8555JD
O80TY208ZW
WQZ3G9PF0H
2HU33I03UY
18E7415PXQ
FGL3685T2X
SML2Y3J35T
M9VVZ08EKQ
VB06AV5US8
Load more...QI7G114Y98
C5529G5JPQ
T7S323PKJS
OZU2FC70HY
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cytochrome P450 3A4 Inhibitors [MoA]
P-Glycoprotein Interactions [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Alkaloid [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Non-Standardized Food Allergenic Extract [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Alkaloids [CS]
Allergens [CS]
Dietary Proteins [CS]
Plant Proteins [CS]
Food Additives [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Alkaloid [EPC]
Alkaloids [CS]
Allergens [CS]
Cell-mediated Immunity [PE]
Cytochrome P450 3A4 Inhibitors [MoA]
Dietary Proteins [CS]
Food Additives [CS]
Increased Histamine Release [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
P-Glycoprotein Interactions [MoA]
Plant Proteins [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 35781-0210-1 | 1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1) / 10 mL in 1 BOTTLE, DISPENSING | 01 Dec, 2011 | N/A | No |
| 35781-0210-2 | 1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-2) / 30 mL in 1 BOTTLE, DISPENSING | 01 Dec, 2011 | N/A | No |
| 35781-0210-9 | 1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-9) / 90 mL in 1 BOTTLE, DISPENSING | 01 Dec, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Speedgel rx echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum, zingiber officinale water isopropyl myristate lecithin, soybean urea docusate sodium sodium hydroxide echinacea angustifolia echinacea angustifolia echinacea purpurea echinacea purpurea aconitum napellus aconitum napellus arnica montana arnica montana calendula officinalis flowering top calendula officinalis flowering top hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark atropa belladonna atropa belladonna bellis perennis bellis perennis chamomile chamomile achillea millefolium achillea millefolium hypericum oil hypericum oil comfrey root comfrey root colchicine colchicine ginger ginger
Indications and Usage:
Indications and usage speedgel rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.
Warnings:
Warnings for external use only. direct patient not to ingest speedgel rx and to avoid contact with the eyes and mucous membranes, wounds, and damaged skin. if condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, patient should consult a doctor. if a rash develops, patient should discontinue use until rash clears. after the disappearance of rash, patient can try speedgel rx again on a test area and monitor the site for additional results. if no rash or redness results, then patient can resume use. however, if the rash persists or redevelops, use should be discontinued. direct patient to keep this product out of reach of children and seek medical help or contact a poison control center immediately if swallowed.
Dosage and Administration:
Dosage and administration apply 1 ml (4 pumps of the bottle) as a thin layer to the affected area 3-4 times daily and rub in gently (wash hands after application). applications of less than 3-4 times daily will not produce optimum results. excess amounts may be wiped from the area. safe to use on children over the age of 2 years. applications of less than 3-4 times a day will not produce optimum results. excess drops may be wiped from the area.
Contraindications:
Contraindications known sensitivity to any of the active or inactive ingredients of speedgel rx®.
Adverse Reactions:
Adverse reactions rarely, allergic skin reactions may occur. if allergic reactions occur, discontinue use of the drug.
Description:
Description speedgel rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented isopeutic⢠transdermal technology. the gensco® patented transdermal drug delivery system used in speedgel rx® carries proprietary formulation of active ingredients, through the skin to the locally affected tissues. speedgel rx® is applied directly to the affected site specifically, minimizing side effects, interactions and comorbidities caused by oral therapies and topical nsaids. furthermore, speedgel rx® is clinically proven to reduce narcotic use. speedgel rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. speedgel rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. among the prescription ingredients is colchicinum autumnale also known as colchicine, which is a well-known, strong and effective anti-inflammatory medication. it contains the following active ingredients : aconitum napellus 3x hpus, arnica montana 1x hpus, belladonna 3x hpus, bellis perennis 1x hpus, calendula officinalis 1x hpus, chamomilla 1x hpus, colchicinum 3x hpus, echinacea angustifolia 1x hpus, echinacea purpurea 1x hpus, hamamelis virginiana 1x hpus, hypericum perforatum 1x hpus, millefolium 1x hpus, symphytum officinale 3x hpus, zingiber officinale 1x hpus. it also contains the following inactive ingredients : docusate sodium, ethyl alcohol, isopropyl myristate, lecithin, purified water & urea. the patented transdermal gelâs liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. the unique transdermal characteristics in speedgel rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. as a topically applied transdermal medication, speedgel rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications. speedgel rx® is an amber colored, odorless gel dispensed in a patented metered dose container (mdose) containing either 10ml, 30ml, or 90ml. genscoâs unique metered dose technology (mdoseâ¢) which dispenses exactly (0.25 ml of medication per pump) per application, covering a 2âx2â area of skin. mdose provides more accurate dosing, less waste and significant cost savings (gensco® pharma tube vs. pump study).
Clinical Pharmacology:
Clinical pharmacology speedgel rx® is a drug under fda regulation and hpus monograph. the active ingredients of speedgel rx® are listed and described within the homeopathic pharmacopeia of the united states (hpus), the official fda compendium of homeopathic drugs. the homeopathic pharmacopeia of the united states (hpus), the officially recognized fda reference source for homeopathic compounds in the u.s., identifies the ingredients of speedgel rx® as shown in table 1.: ingredients common name indications aconitum napellus monkâs-hood neuralgia, rheumatism, hemostasis, analgesia arnica montana mountain arnica stimulates healing of injured tissues, wounds, contusions, hematomas, neuralgia, myalgia, analgesia belladonna deadly nightshade inflammation locally bellis perennis daisy dislocations, bruising, reducing edema calendula officinalis calendula analgesia, inflammation colchicinum colchicine inflammation and gout chamomilla chamomile inflammation, promotes healing of tis
Read more...sues echinacea angustifolia narrow leaf cone flower inflammation and inhibits hyaluronidase echinacea purpurea purple cone flower stimulates fibroblasts, inflammation hamamelis virginiana witch-hazel astringent, analgesic, hematomas hypericum perforatum st. johnâs wort neuropathic pains millefolium yarrow hematomas, wound healing symphytum officinale comfrey neuropathy, causalgia, contusions, periostitis zingiber officinale ginger inflammation bolded items are at strengths recognized by the hpus as requiring a prescription.
How Supplied:
How supplied/storage and handling ndc 35781-0210-1 homeopathic transdermal pain relief gel rx only net contents 0.33 fl oz (10 ml) package size: 0.33 fl oz (10ml) bottle ndc 35781-0210-2 homeopathic transdermal pain relief gel rx only net contents 1.01 fl oz (30 ml) package size: 1.01 fl oz (30ml) bottle ndc 35781-0210-9 homeopathic transdermal pain relief gel rx only net contents 3.04 fl oz (90 ml) package size: 3.04 fl oz (90ml) bottle manufactured for: manufactured for: gensco pharma, llc 8550 nw 33rd street, suite 200. miami, fl 33122 (855) 743-6726 www.genscopharma.com
Package Label Principal Display Panel:
Box-10ml
Box-30ml
Box-90ml
Label