Prescription Drugs

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

SpeedGel Homeopathic Topical Analgesic Gel 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 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 HaPUS, 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, Isopropyl myristate, Lecithin, Purified water, Sodium hydroxide, Urea.

INDICATIONS 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. 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 over a 24-hour period, or as directed by a physician, 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. Safe to use on children over age of 2 years. HOW SUPPLIED Package Size: 1.01 fl oz (30mL) bottle 0.33 fl oz (10mL) bottle NDC 35781-0210-1 1.01 fl oz (30mL) bottle NDC 35781-0210-2 Manufactured for: Gensco Laboratories, LLC, Miami, FL 33122.

PATIENT INFORMATION No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS Known sensitivity to Arnica montana.

SIDE EFFECTS Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days. DRUG INTERACTIONS No information provided.

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.