NDC 35356-647 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

NDC Product Code 35356-647

NDC CODE: 35356-647

Proprietary Name: Speedgel Rx 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, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale 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

NDC 35356-647-10

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 10 mL in 1 BOTTLE, DISPENSING

NDC 35356-647-30

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 30 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Speedgel Rx with NDC 35356-647 is a a human prescription drug product labeled by Lake Erie Medical Dba Quality Care Products Llc. The generic name of Speedgel Rx is echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum, zingiber officinale. The product's dosage form is gel and is administered via transdermal form.

Labeler Name: Lake Erie Medical Dba Quality Care Products Llc

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 Prescription 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.

Speedgel Rx 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]/30mL
  • ECHINACEA PURPUREA 1 [hp_X]/30mL
  • ACONITUM NAPELLUS 3 [hp_X]/30mL
  • ARNICA MONTANA 1 [hp_X]/30mL
  • CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/30mL
  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/30mL
  • ATROPA BELLADONNA 3 [hp_X]/30mL
  • BELLIS PERENNIS 1 [hp_X]/30mL
  • CHAMOMILE 1 [hp_X]/30mL
  • ACHILLEA MILLEFOLIUM 1 [hp_X]/30mL
  • HYPERICUM OIL 1 [hp_X]/30mL
  • COMFREY ROOT 3 [hp_X]/30mL
  • COLCHICINE 3 [hp_X]/30mL
  • GINGER 1 [hp_X]/30mL

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)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • UREA (UNII: 8W8T17847W)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Interactions - [MoA] (Mechanism of Action)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Plant Proteins - [CS]
  • Food Additives - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lake Erie Medical Dba Quality Care Products Llc
Labeler Code: 35356
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: 12-01-2011 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Speedgel Rx Product Label Images

Speedgel Rx 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

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

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
Monk’s-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 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. John’s wort
Neuropathic pains
Millefolium
Yarrow
Hematomas, wound healing
Symphytum Officinale
Comfrey
Neuropathy, causalgia,
contusions, periostitis
Zingiber Officinale
Ginger
Inflammation

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.

Contraindications

Known sensitivity to Arnica Montana or any other ingredient.

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.

Precautions

Use in Pregnancy: No human or animal studies on the effect of SPEEDGEL RX in pregnancy have been conducted.
Nursing Mothers: It is not known whether SPEEDGEL RX is excreted in breast milk.

Adverse Reactions

Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug.

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.

How Supplied/Storage And Handling

35356-647-1035356-647-30HOMEOPATHIC TRANSDERMAL PAIN RELIEF GELRX ONLY NET CONTENTS 1.01 FL OZ (30 ML)Package Size: 1.01 fl oz (30ml) bottleUS Patent #5,634,337 Manufactured for:Gensco Laboratories,LLCInverness, FL 34452866-608-6284 www.speedgelrx.com

* Please review the disclaimer below.