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 All Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

SPEEDGEL RX is a homeopathic topical analgesic gel that contains the ingredients listed below.Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions. It is an amber colored odorless gel for use externally to control inflammation and reduce pain.

It contains the following active ingredients:

Aconitum Napellus 3X, Arnica Montana 3X, Belladonna 3X, Bellis Perennis 1X, Calendula Officinalis 1X, Colchicinum 3X, Chamomilla 1X, Echinacea Angustifolia 1X, Echinacea Purpurea 1X, Hamamelis Virginiana 1X, Hypericum Perforatum 1X, Millefolium 1X, Symphytum Officinale 3X, Zingiber Officinale 1X.

It also contains the following inactive ingredients:

Purified water, Urea, Isopropyl myristate, Lecithin, Docusate sodium, Sodium hydroxide.

CLINICAL PHARMACOLOGY

The exact pharmacology by which SpeedGel RX works to control aches and pains 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 such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes is unknown. It is theorized that, according to traditional homeopathy, the following ingredients contribute in the following ways:

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

INDICATIONS AND USAGE

SPEEDGEL RX is indicated for the relief of pain and inflammation from: arthritis or injuries such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic edema, post-surgical edema, general swelling of joints and soft tissues of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe and general aches and pains.

CONTRAINDICATIONS

Known sensitivity to Arnica Montana or any other ingredient.

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.

ADVERSE REACTIONS

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

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.

HOW SUPPLIED/STORAGE AND HANDLING

NDC: 53149-9074-2 30 mL in a BOTTLE

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

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: 53149-9074(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: 53149-9074-2	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2016

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

Labeler - All Pharma, LLC (078572520)

Registrant - All Pharma, LLC (078572520)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma, LLC		078572520	MANUFACTURE(53149-9074) , REPACK(53149-9074)