SPEEDGEL RX

Manufacturer
All Pharma, LLC
Effective date
2016-08-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:23:06

Label at a glance#

ProductSPEEDGEL RX
Active ingredientECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, BELLIS PERENNIS, CHAMOMILE, ACHILLEA MILLEFOLIUM, HYPERICUM OIL, COMFREY ROOT, COLCHICINE, GINGER
Label structure10 sections

Indications and uses

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.

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.

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

Known sensitivity to Arnica Montana or any other ingredient.

WARNINGS

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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, ZINGIBE...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53149-9074-22020-10-16C16284748780-19d75b9d0-4c6f-f424-e053-dadaa90a57ceSPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC
53149-9074-22020-01-31C16284748780-19d75b9d0-4c6f-f424-e053-dadaa90a57ceSPEEDGEL RX TOPICAL ANTI-INFLAMATORY/ANALGESIC

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0210-1ML - Milliliter35781-021011a97c98-f8ca-4730-b7ad-18e5c84f19b412013-02-13
35781-0210-2ML - Milliliter35781-0210cd484876-f4a4-4c51-9801-04b6418d1f3312013-02-13
35781-0210-9ML - Milliliter35781-02106aab4839-0147-4103-a899-6bbf99c905f712015-10-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53149-907453149-9074-2
35781-0210

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e632b568-4b5b-4555-8972-636126beb9bbf1932216-e8d1-4fb6-991e-c335b9b7ad922020-10-16Warnings, Adverse reactionsExact identifier
spl set id: f1932216-e8d1-4fb6-991e-c335b9b7ad92

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.