Tranzgel
FDA Label NDC 35781-0194

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gensco Laboratories, Llc for the product Tranzgel (NDC 35781-0194). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, package label.principal display panel, other, description, physical information, clinical pharmacology, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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


Tranzgel_bottle_label (Tranzgel Label)

Tranzgel_bottle_label (Tranzgel Label)

Tranzgel_carton_label (Tranzgel Carton)

Tranzgel_carton_label (Tranzgel Carton)

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


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