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

Lake Erie Medical Dba Quality Care Products Llc
Human Prescription Drug
NDC 35356-647

Speedgel 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 'Lake Erie Medical Dba Quality Care Products Llc'. National Drug Code (NDC) number for Speedgel Rx is 35356-647. 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:	35356-647
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:	Lake Erie Medical Dba Quality Care Products 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:	Lake Erie Medical DBA Quality Care Products LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
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:	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
35356-647-10	1 BOTTLE, DISPENSING in 1 CARTON (35356-647-10) / 10 mL in 1 BOTTLE, DISPENSING	23 Aug, 2013	N/A	No
35356-647-30	1 BOTTLE, DISPENSING in 1 CARTON (35356-647-30) / 30 mL in 1 BOTTLE, DISPENSING	23 Aug, 2013	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.

Other medicines with the same generic name

Speedgel Rx

Echinacea Angustifolia & more..

Gel
Lake Erie Medical DBA Quality Care Products LLC
NDC: 35356-647

Speedgel Rx

Echinacea Angustifolia & more..

Gel
Gensco Laboratories, LLC
NDC: 35781-0210

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 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 water isopropyl myristate lecithin, soybean urea docusate sodium sodium hydroxide

Indications and Usage:

Indications and usage speedgel rx is indicated for the relief of pain and inflammation from: arthritis or injuries such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic edema, post-surgical edema, general swelling of joints and soft tissues of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe and general aches and pains.

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 a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area 3-4 times daily and rub in gently. 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 arnica montana or any other ingredient.

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 homeopathic topical analgesic gel that contains the ingredients listed below.homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions. it is an amber colored odorless gel for use externally to control inflammation and reduce pain. it contains the following active ingredients: aconitum napellus 3x, arnica montana 3x, belladonna 3x, bellis perennis 1x, calendula officinalis 1x, colchicinum 3x, chamomilla 1x, echinacea angustifolia 1x, echinacea purpurea 1x, hamamelis virginiana 1x, hypericum perforatum 1x, millefolium 1x, symphytum officinale 3x, zingiber officinale 1x. it also contains the following inactive ingredients: purified water, urea, isopropyl myristate, lecithin, docusate sodium, sodium hydroxide.

Clinical Pharmacology:

Clinical pharmacology the exact pharmacology by which speedgel rx works to control aches and pains associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic edema, post-surgical edema, hematoma, general swelling of joints and soft tissues) to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes is unknown. it is theorized that, according to traditional homeopathy, the following ingredients contribute in the following ways: 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 in Read more...

flammation, promotes healing of tissues 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

How Supplied:

How supplied/storage and handling 35356-647-10 35356-647-30 homeopathic transdermal pain relief gel rx only net contents 1.01 fl oz (30 ml) package size: 1.01 fl oz (30ml) bottle us patent #5,634,337 manufactured for: gensco laboratories,llc inverness, fl 34452 866-608-6284 www.speedgelrx.com

Package Label Principal Display Panel:

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Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.