SPEEDGEL RX

Lake Erie Medical DBA Quality Care Products LLC

SPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC

FULL PRESCRIBING INFORMATION: CONTENTS*

• SPEEDGEL RX DESCRIPTION
• CLINICAL PHARMACOLOGY
• SPEEDGEL RX INDICATIONS AND USAGE
• SPEEDGEL RX CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• SPEEDGEL RX ADVERSE REACTIONS
• SPEEDGEL RX DOSAGE AND ADMINISTRATION
• HOW SUPPLIED/STORAGE AND HANDLING
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FULL PRESCRIBING INFORMATION

SPEEDGEL RX 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.

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:

SPEEDGEL RX 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.

SPEEDGEL RX CONTRAINDICATIONS

Known sensitivity to Arnica Montana or any other ingredient.

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.

SPEEDGEL RX ADVERSE REACTIONS

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

SPEEDGEL RX 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.

HOW SUPPLIED/STORAGE AND HANDLING

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

US Patent #5,634,337

Manufactured for:

Gensco Laboratories,LLC

Inverness, FL 34452

866-608-6284

www.speedgelrx.com

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