FDA Label for Speedgel Rx
View Indications, Usage & Precautions
Speedgel Rx Product Label
The following document was submitted to the FDA by the labeler of this product Gensco Laboratories, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 gel’s 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. Gensco’s unique metered dose technology (MDose™) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study).
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 | 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 |
Bolded items are at strengths recognized by the HPUS as requiring a prescription.
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.
Contraindications
Known sensitivity to any of the active or inactive ingredients of SpeedGel Rx®.
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.
Females & Males Of Reproductive Potential
No human or animal studies on the effect of SpeedGel Rx® in females & males of reproductive potential have been conducted.
Adverse Reactions
Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug.
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.
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
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