TRANZGEL- echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum gel

TRANZGEL by

Drug Labeling and Warnings

TRANZGEL by is a Homeopathic medication manufactured, distributed, or labeled by Gensco Laboratories, LLC, Formulated Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE

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

PRINCIPAL DISPLAY PANEL

TRANZ GEL

HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL

RX ONLY NET CONTENTS 1.7 FL OZ (50 ML)

GENSCO LABORATORIES

SPL UNCLASSIFIED SECTION

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

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

PURIFIED WATER, ISOPROPYL MYRISTATE, LECITHIN, UREA, DOCUSATE SODIUM, SODIUM HYDROXIDE

SPL UNCLASSIFIED SECTION

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.

ACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRANZGEL 
echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35781-0194
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X]  in 50 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X]  in 50 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 50 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 50 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 50 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]  in 50 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 50 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 50 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X]  in 50 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	1 [hp_X]  in 50 mL
HYPERICUM OIL (UNII: OZU2FC70HY) (HYPERICUM OIL - UNII:OZU2FC70HY)	HYPERICUM OIL	6 [hp_X]  in 50 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	4 [hp_X]  in 50 mL
COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)	COLCHICINE	3 [hp_X]  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
UREA (UNII: 8W8T17847W)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35781-0194-5	1 in 1 CARTON
1		50 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2010

Labeler - Gensco Laboratories, LLC (831042325)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions		143266687	manufacture