Label: SPEEDGEL RX- echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, atropa belladonna, bellis perennis, chamomile, achillea millefolium, hypericum oil, comfrey root, colchicine and ginger gel 

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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 12/11

If you are a consumer or patient please visit this version.

  • 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.

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  • 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

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  • 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.

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  • CONTRAINDICATIONS

    Known sensitivity to Arnica Montana or any other ingredient.

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  • 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.

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  • 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.

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  • ADVERSE REACTIONS

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

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  • 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.


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  • SPEED GEL PAIN RELIEF
  • 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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50436-9072(NDC:35781-0210)
    Route of Administration TRANSDERMAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 1 [hp_X]  in 30 mL
    ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 1 [hp_X]  in 30 mL
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]  in 30 mL
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_X]  in 30 mL
    CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]  in 30 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]  in 30 mL
    ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 3 [hp_X]  in 30 mL
    BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 1 [hp_X]  in 30 mL
    CHAMOMILE (CHAMOMILE) CHAMOMILE 1 [hp_X]  in 30 mL
    ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 1 [hp_X]  in 30 mL
    HYPERICUM OIL (HYPERICUM OIL) HYPERICUM OIL 1 [hp_X]  in 30 mL
    COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 3 [hp_X]  in 30 mL
    COLCHICINE (COLCHICINE) COLCHICINE 3 [hp_X]  in 30 mL
    GINGER (GINGER) GINGER 1 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ISOPROPYL MYRISTATE  
    LECITHIN, SOYBEAN  
    UREA  
    DOCUSATE SODIUM  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-9072-1 1 in 1 CARTON
    1 30 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/01/2011
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK
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