Label: 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 gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 5, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 NameIndications

    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

  • PRINCIPAL DISPLAY PANEL

    Box-10mL
  • PRINCIPAL DISPLAY PANEL

    Box-30mL
  • PRINCIPAL DISPLAY PANEL

    Box-90mL
  • PRINCIPAL DISPLAY PANEL

    Label
  • INGREDIENTS AND APPEARANCE
    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 gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:35781-0210
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 30 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 30 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 30 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 30 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 30 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 30 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 30 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 [hp_X]  in 30 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 30 mL
    HYPERICUM OIL (UNII: OZU2FC70HY) (HYPERICUM OIL - UNII:OZU2FC70HY) HYPERICUM OIL1 [hp_X]  in 30 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 30 mL
    COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T) COLCHICINE3 [hp_X]  in 30 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER1 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    UREA (UNII: 8W8T17847W)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35781-0210-21 in 1 CARTON12/01/2011
    130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:35781-0210-11 in 1 CARTON12/01/2011
    210 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    3NDC:35781-0210-91 in 1 CARTON12/01/2011
    390 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2011
    Labeler - Gensco Laboratories, LLC (831042325)
    Registrant - Gensco Laboratories, LLC (831042325)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC117605075manufacture(35781-0210)