FDA Label for Rapid Gel Rx
View Indications, Usage & Precautions
Rapid Gel Rx Product Label
The following document was submitted to the FDA by the labeler of this product Tmig Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Rapid Gel 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 a white 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 Rapid Gel 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 |
Indications And Usage
Rapid Gel 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.
Contraindications
Known sensitivity to Arnica Montana or any other ingredient.
Precautions
Use in Pregnancy: No human or animal studies on the effect of Rapid Gel RX in pregnancy have been conducted.
Nursing Mothers: It is not known whether Rapid Gel RX is excreted in breast milk.
Adverse Reactions
Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug.
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 69176-070-30
HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL
RX ONLY NET CONTENTS 30g
NDC 69176-070-90
HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL
RX ONLY NET CONTENTS 90g
Manufactured for:
TMIG Inc.
Marietta, GA
Warnings
For external use only. Direct patient not to ingest Rapid Gel 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 Rapid Gel 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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