speedgel rx

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC
Effective date
2019-07-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:18:19

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

35356-647-10 35356-647-30 HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL RX ONLY NET CONTENTS 1.01 FL OZ (30 ML) Package Size: 1.01 fl oz (30ml) bottle US Patent #5,634,337 Manufactured for: Gensco Laboratories,LLC Inverness, FL 34452 866-608-6284 www.speedgelrx.com

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:


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

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

35356-647-10

35356-647-30

HOMEOPATHIC TRANSDERMAL PAIN RELIEF GEL

RX ONLY NET CONTENTS 1.01 FL OZ (30 ML)

Package Size: 1.01 fl oz (30ml) bottle

US Patent #5,634,337

Manufactured for:

Gensco Laboratories,LLC

Inverness, FL 34452

866-608-6284

www.speedgelrx.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-647-10ML - Milliliter35356-647407ae6ac-46b7-4208-a0a9-76c4a919cf4612016-12-07
35356-647-30ML - Milliliter35356-6479c6fcec7-b5d8-4b4e-bd8a-ecaf90069d0712015-10-02
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACHILLEA MILLEFOLIUMACTIVE INGREDIENT2FXJ6SW4PK1
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
CHAMOMILEACTIVE INGREDIENTFGL3685T2X1
COLCHICINEACTIVE INGREDIENTSML2Y3J35T1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQ1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
ECHINACEA PURPUREAACTIVE INGREDIENTQI7G114Y981
GINGERACTIVE INGREDIENTC5529G5JPQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
HYPERICUM OILACTIVE INGREDIENTOZU2FC70HY1
ACHILLEA MILLEFOLIUMACTIVE MOIETY2FXJ6SW4PK1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
CHAMOMILEACTIVE MOIETYFGL3685T2X1
COLCHICINEACTIVE MOIETYSML2Y3J35T1
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQ1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
ECHINACEA PURPUREAACTIVE MOIETYQI7G114Y981
GINGERACTIVE MOIETYC5529G5JPQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
HYPERICUM OILACTIVE MOIETYOZU2FC70HY1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA01
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
UREAINACTIVE INGREDIENT8W8T17847W1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
35356-64735356-647-30, 35356-647-10
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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 217 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
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UREAUREA8W8T17847WTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
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ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
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ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / TOPICAL213 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
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DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0TABLET / ORAL50 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
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7 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0GEL / TOPICAL6 mgExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
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LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
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ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
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SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
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ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSFILM, EXTENDED RELEASE / TRANSDERMAL20.4 mgExact identifier — unii candidate
18 equally ranked IID candidates
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7 equally ranked IID candidates

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
71650b2e-ff47-4842-ab77-089d65a1482c28561a9a-8a1b-4113-b3bc-ff7e5b329b542023-08-02Warnings, Adverse reactionsExact identifier
spl set id: 28561a9a-8a1b-4113-b3bc-ff7e5b329b54

Reported adverse events (FAERS/openFDA)#

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