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

SPEEDGEL RX by

Drug Labeling and Warnings

SPEEDGEL RX by is a Homeopathic medication manufactured, distributed, or labeled by Gensco Laboratories, LLC, All Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

SpeedGel Rx® is a prescription transdermal gel that provides relief of pain, inflammation and bruising, utilizing patented Isopeutic™
Transdermal Technology. The Gensco® patented transdermal drug delivery system used in SpeedGel Rx® carries proprietary formulation of
active ingredients, through the skin to the locally affected tissues. SpeedGel Rx® is applied directly to the affected site specifically,
minimizing side effects, interactions and comorbidities caused by oral
therapies and topical NSAIDs. Furthermore, SpeedGel Rx® is clinically
proven to reduce narcotic use.

SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation, inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes. SpeedGel Rx® is a proprietary combination of 14 active ingredients, 4 of which are prescription, in a patented transdermal delivery system. Among the prescription ingredients is Colchicinum Autumnale also known as Colchicine, which is a well-known, strong and effective anti-inflammatory medication.

It contains the following active ingredients:
Aconitum Napellus 3X HPUS, Arnica Montana 1X HPUS, Belladonna 3X
HPUS, Bellis Perennis 1X HPUS, Calendula Officinalis 1X HPUS,
Chamomilla 1X HPUS, Colchicinum 3X HPUS, Echinacea Angustifolia
1X HPUS, Echinacea Purpurea 1X HPUS, Hamamelis Virginiana 1X
HPUS, Hypericum Perforatum 1X HPUS, Millefolium 1X HPUS,
Symphytum Officinale 3X HPUS, Zingiber Officinale 1X HPUS.

It also contains the following inactive ingredients:
Docusate sodium, Ethyl Alcohol, Isopropyl myristate, Lecithin, Purified
Water & Urea.

The patented transdermal gel’s liposomal base comprising of hydrophilic and lipophilic components is designed to suspend the active ingredients and allow for the hydration of the skin barrier and movement of the active ingredients, irrespective of their molecular polarity, across the skin at an enhanced rate. The unique transdermal characteristics in SpeedGel Rx® permit the active ingredients to penetrate to the site of injury, diminishing pain and inflammation, and enhancing bruise resolution. As a topically applied transdermal medication,  SpeedGel Rx® avoids the common concerns of toxicity and drug interactions associated with systemic (oral) medications.

SpeedGel Rx® is an amber colored, odorless gel dispensed in a patented metered dose container (MDose) containing either 10ml, 30ml, or 90ml. Gensco’s unique metered dose technology (MDose™) which dispenses exactly (0.25 mL of medication per pump) per application, covering a 2”x2” area of skin. MDose provides more accurate dosing, less waste and significant cost savings (Gensco® Pharma Tube vs. Pump Study).

CLINICAL PHARMACOLOGY

SpeedGel Rx® is a drug under FDA regulation and HPUS monograph. The active ingredients of SpeedGel Rx® are listed and described within
the Homeopathic Pharmacopeia of the United States (HPUS), the official FDA compendium of homeopathic drugs.

The Homeopathic Pharmacopeia of the United States (HPUS), the officially recognized FDA reference source for homeopathic compounds
in the U.S., identifies the ingredients of SpeedGel Rx® as shown in TABLE 1.:

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

Bolded items are at strengths recognized by the HPUS as requiring a prescription.

INDICATIONS AND USAGE

SpeedGel Rx® is indicated for the relief of pain, inflammation and bruising from musculoskeletal pain and associated inflammation,
inflammatory conditions of joints and soft tissues, arthritis, injuries such as sprains, strains, and disclocations, repetitive/overuse injuries, general aches and pains, contusions and trauma to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes.

CONTRAINDICATIONS

Known sensitivity to any of the active or inactive ingredients of SpeedGel Rx®.

WARNINGS

For external use only. Direct patient not to ingest SPEEDGEL 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 SPEEDGEL 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.

PRECAUTIONS

Use in Pregnancy: No human or animal studies on the effect of SPEEDGEL RX in pregnancy have been conducted.

Nursing Mothers: It is not known whether SPEEDGEL RX is excreted in breast milk.

FEMALES & MALES OF REPRODUCTIVE POTENTIAL

No human or animal studies on the effect of SpeedGel Rx® in females & males of reproductive potential have been conducted.

ADVERSE REACTIONS

Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug.

DOSAGE AND ADMINISTRATION

Apply 1 ml (4 pumps of the bottle) as a thin layer to the affected area 3-4 times daily and rub in gently (wash hands after application). Applications of less than 3-4 times daily will not produce optimum results. Excess amounts may be wiped from the area. Safe to use on children over the age of 2 years.

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: 35781-0210-1 HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 0.33 FL OZ (10 ML) Package Size: 0.33 fl oz (10ml) bottle NDC: 35781-0210-2 HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 1.01 FL OZ (30 ML) Package Size: 1.01 fl oz (30ml) bottle NDC: 35781-0210-9 HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 3.04 FL OZ (90 ML) Package Size: 3.04 fl oz (90ml) bottle Manufactured for: Manufactured for: Gensco Pharma, LLC 8550 NW 33rd Street, Suite 200. Miami, FL 33122 (855) 743-6726 www.genscopharma.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35781-0210
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 30 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X]  in 30 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 30 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 30 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 30 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 30 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 30 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	1 [hp_X]  in 30 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X]  in 30 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	1 [hp_X]  in 30 mL
HYPERICUM OIL (UNII: OZU2FC70HY) (HYPERICUM OIL - UNII:OZU2FC70HY)	HYPERICUM OIL	1 [hp_X]  in 30 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 30 mL
COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)	COLCHICINE	3 [hp_X]  in 30 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	1 [hp_X]  in 30 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: 35781-0210-2	1 in 1 CARTON	12/01/2011
1		30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
2	NDC: 35781-0210-1	1 in 1 CARTON	12/01/2011
2		10 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
3	NDC: 35781-0210-9	1 in 1 CARTON	12/01/2011
3		90 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2011

Labeler - Gensco Laboratories, LLC (831042325)

Registrant - Gensco Laboratories, LLC (831042325)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma LLC		078572520	manufacture(35781-0210)