FDA Label for Tranzgel
View Indications, Usage & Precautions
Tranzgel Product Label
The following document was submitted to the FDA by the labeler of this product Gensco Laboratories, Llc. 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.
Otc - Active Ingredient
ACTIVE INGREDIENTS:
ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS
ACTIVE INGREDIENTS:
ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, ACONITUM NAPELLUS 3X HPUS, ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, BELLADONNA 3X HPUS, BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, MILLEFOLIUM 1X HPUS, HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, COLCHICINUM 3X HPUS
ACTIVE INGREDIENTS:
50 PARTS EACH: ECHINACEA ANGUSTIFOLIA 1X HPUS, ECHINACEA PUPUREA 1X HPUS, 30 PARTS: ACONITUM NAPELLUS 3X HPUS, 15 PARTS EACH: ARNICA MONTANA 3X HPUS, CALENDULA OFFICIANALIS 1X HPUS, HAMAMELIS VIRGINIANA 1X HPUS, 10 PARTS: BELLADONNA 3X HPUS, 5 PARTS EACH: BELLIS PERENNIS 1X HPUS, CHAMOMILLA 1X HPUS, 3 PARTS MILLEFOLIUM 1X HPUS, 1 PART EACH: HYPERICUM PERFORATUM 6X HPUS, SYMPHYTUM OFFICINALE 4X HPUS, .01 PART COLCHICINUM 3X HPUS
Inactive Ingredient
INACTIVE INGREDIENTS:
PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE
INACTIVE INGREDIENTS:
PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE
INACTIVE INGREDIENTS:
PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE
Package Label.Principal Display Panel
NDC 35781-0194-5
TRANZGEL
HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL
RX ONLY NET CONTENTS 1.7 FL OZ (50 ML)
GENSCO LABORATORIES, LLC
FOR COMPLETE PRESCRIBING INFORMATION, SEE PACKAGE INSERT. STORE AT ROOM TEMPERATURE.
MANUFACTURED BY FORMULATED SOLUTIONS
CLEARWATER, FL 33760
US PATENT #5,654,337
MANUFACTURED FOR GENSCO LABORATORIES, LLC
INVERNESS, FL 34452
352.726.6284
866.608.6284
WWW.TRANZGEL.COM
TRANZ GEL
HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL
RX ONLY NET CONTENTS 1.7 FL OZ (50 ML)
GENSCO LABORATORIES
Other
MANUFACTURED BY
FORMULATED SOLUTIONS, LLC
CLEARWATER FL 33760
US PATENT #5,654,337
MANUFACTURED BY
GENSCO LABORATORIES, LLC
INVERNESS, FL 34452
352.726.6284
866.608.6284
WWW.TRANZGEL.COM
For complete prescribing information, see package insert. Store at room temperature.
Description
DESCRIPTION
A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.
Physical Information
PHYSICAL INFORMATION
A clear amber colored, viscous gel with a slight floral smell.
Clinical Pharmacology
CLINICAL PHARMACOLOGY
According to traditional homeopathic literature and Material Medica, the following ingredients provide the following attributes:
INGREDIENTS COMMON NAME INDICATIONS
Arnica Montana Mountain arnica Stimulates healing of injured tissues wounds, contusions, hematomas, neuralgia myalgia, analgesia
Calendula Officianalis Calendula Inflammation
Hamamelis Virginiana Witch-hazel Analgesic
Millefolium Yarrow Hematomas
Belladonna Banewort Inflammation locally
Aconitum Napellus Monk's hood Neuralgia, rheumatism hemostasis, analgeisa
Chamomilla Chamomile Inflammation, nausea
Colchicinum Colchicine Inflammation and gout
Symphytum Officinale Comfrey Neuropathy, contusions, tendonitis, arthritis
Bellis Perennis Daisy brusing, edema, arthralgia
Echinacea Angustifolia Narrow leaf cone flower Inflammation, myalgia
Echinacia purpurea purple cone flower Inflammation, myalgia
Hypericum perforatum st. john's wort neuropathic pains
Indications & Usage
INDICATIONS AND USAGE
The drug is indicated for the relief of symptoms, including pain and inflammation 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 areas such as hand, wrist elbow, shoulder, neck, back, knees, ankles, feet and toes.
Contraindications
CONTRAINDICATIONS
This drug should not be used by those sensitive to Arnica or any of the other listed ingredients.
Warnings And Precautions
WARNINGS AND PRECAUTIONS
For external use only. direct patient not to ingest TRANZEL and to avoid contact with they eyes, mucous membranes, wounds, and damaged skin. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try TRANZGEL 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 the patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.
In the homeopathic concentrations used to make TRANZGEL, there are no known or expected interactions with other drugs or laboratory tests. In addition, the homeopathic concentrations used are below any levels with known or suspected toxicities.
Overdosage
OVERDOSAGE
According to toxicology studies, a patient would have to orally ingest a minimum of 22 bottles of TRANZGEL to experience any initial toxic effects.
Adverse Reactions
ADVERSE REACTIONS
Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days.
Dosage & 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
Package size: 1.7 fl oz (50 ml) airless pump dispensing bottle
US PATENT 5,654,337
NDC 35781-0194-5
Information For Patients
STORE AT ROOM TEMPERATURE
Manufactured by
Formulated Solutions, LLC
Clearwater, FL 33760
Manufactured for
Gensco Laboratories, LLC
Inverness, FL 34452
352-726-6284
866-608-6284
www.tranzgel.com
* Please review the disclaimer below.