Tranzgel Homeopathic Transdermal Pain Relief Gel

Tranzgel Homeopathic Transdermal Pain Relief Gel
SPL v2
SPL
SPL Set ID abc4b131-4d35-46a4-9a8e-9bd4c7a0f4b0
Route
TRANSDERMAL
Published
Effective Date 2010-07-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (1 [hp_X]) Echinacea Purpurea (3 [hp_X]) Aconitum Napellus (6 [hp_X]) Arnica Montana (4 [hp_X]) Calendula Officinalis Flowering Top Hamamelis Virginiana Root Bark/stem Bark Atropa Belladonna Bellis Perennis Chamomile Achillea Millefolium Hypericum Oil Comfrey Root Colchicine
Inactive Ingredients
Water Isopropyl Myristate Lecithin, Soybean Urea Docusate Sodium Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-07-01

Description

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


Medication Information

Indications and 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.

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.

Dosage Forms and Strengths

Package size: 1.7 fl oz (50 ml) airless pump dispensing bottle

US PATENT 5,654,337

NDC 35781-0194-5

Contraindications

CONTRAINDICATIONS

This drug should not be used by those sensitive to Arnica or any of the other listed ingredients.

Description

DESCRIPTION

A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.

Section 34076-0

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



Section 34084-4

ADVERSE REACTIONS

Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days.

Section 34088-5

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.

Section 34090-1

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









Section 42229-5

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



Section 43685-7

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.

Section 51727-6

INACTIVE INGREDIENTS:

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

Section 51945-4

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

Section 55106-9

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

Physical Information

PHYSICAL INFORMATION

A clear amber colored, viscous gel with a slight floral smell.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Dosage Forms and Strengths (34069-5)

Package size: 1.7 fl oz (50 ml) airless pump dispensing bottle

US PATENT 5,654,337

NDC 35781-0194-5

Contraindications (34070-3)

CONTRAINDICATIONS

This drug should not be used by those sensitive to Arnica or any of the other listed ingredients.

Section 34076-0 (34076-0)

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



Section 34084-4 (34084-4)

ADVERSE REACTIONS

Rarely, allergic skin reactions may occur. These effects are transient and will clear after a few days.

Section 34088-5 (34088-5)

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.

Description (34089-3)

DESCRIPTION

A homeopathic topical analgesic gel that contains the active ingredients indicated below in the corresponding concentrations.

Section 34090-1 (34090-1)

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









Section 42229-5 (42229-5)

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



Section 43685-7 (43685-7)

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.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

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

Section 51945-4 (51945-4)

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

Section 55106-9 (55106-9)

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

Physical Information

PHYSICAL INFORMATION

A clear amber colored, viscous gel with a slight floral smell.


Advanced Ingredient Data


Raw Label Data

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