Your browser does not support JavaScript! 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 [UNIT DOSE SERVICES]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Out of scope

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
[Unit Dose Services]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved homeopathic
NOTE:THIS HOMEOPATHIC PRODUCT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION FOR SAFETY OR EFFICACY. FDA IS NOT AWARE OF SCIENTIFIC EVIDENCE TO SUPPORT HOMEOPATHY AS EFFECTIVE.
Drug Label Sections

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:


IngredientsCommon NameIndications

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.


SPEED GEL PAIN RELIEF

Label Image
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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50436-9072(NDC:35781-0210)
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 30 mL
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA1 [hp_X]  in 30 mL
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS3 [hp_X]  in 30 mL
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA1 [hp_X]  in 30 mL
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 30 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 30 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA3 [hp_X]  in 30 mL
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS1 [hp_X]  in 30 mL
CHAMOMILE (CHAMOMILE) CHAMOMILE1 [hp_X]  in 30 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM1 [hp_X]  in 30 mL
HYPERICUM OIL (HYPERICUM OIL) HYPERICUM OIL1 [hp_X]  in 30 mL
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT3 [hp_X]  in 30 mL
COLCHICINE (COLCHICINE) COLCHICINE3 [hp_X]  in 30 mL
GINGER (GINGER) GINGER1 [hp_X]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL MYRISTATE 
LECITHIN, SOYBEAN 
UREA 
DOCUSATE SODIUM 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-9072-11 in 1 CARTON
130 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2011
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIBusiness Operations
Unit Dose Services831995316REPACK

Revised: 12/2011
 
Unit Dose Services

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services