{"adverse_reactions":["ADVERSE REACTIONS Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug."],"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 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."],"clinical_pharmacology_table":["
Ingredients Common NameIndications
Aconitum NapellusMonk’s-hoodNeuralgia, rheumatism,hemostasis, analgesia
Arnica MontanaMountain arnicaStimulates healing of injuredtissues, wounds, contusions,hematomas, neuralgia, myalgia,analgesia
BelladonnaDeadly nightshadeInflammation locally
Bellis PerennisDaisyDislocations, bruising,reducing edema
Calendula OfficinalisCalendulaAnalgesia, inflammation
ColchicinumColchicineInflammation and gout
ChamomillaChamomileInflammation, promoteshealing of tissues
Echinacea AngustifoliaNarrow leaf cone flowerInflammation and inhibitshyaluronidase
Echinacea PurpureaPurple cone flowerStimulates fibroblasts,inflammation
Hamamelis VirginianaWitch-hazelAstringent, analgesic, hematomas
Hypericum PerforatumSt. John’s wortNeuropathic pains
MillefoliumYarrowHematomas, wound healing
Symphytum OfficinaleComfreyNeuropathy, causalgia,contusions, periostitis
Zingiber OfficinaleGingerInflammation
"],"contraindications":["CONTRAINDICATIONS Known sensitivity to any of the active or inactive ingredients of SpeedGel Rx®."],"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 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)."],"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."],"effective_time":"20221005","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"],"id":"ea4e4eac-3e35-5370-e053-2995a90a9cab","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."],"openfda":{},"package_label_principal_display_panel":["Box-10mL","Box-30mL","Box-90mL","Label"],"precautions":["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."],"set_id":"abc4b132-4d35-46a4-9a8e-9bd4c7a0f4b0","spl_product_data_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"],"spl_unclassified_section":["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."],"version":"8","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."]}