Label: 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
- NDC Code(s): 50436-9072-1
- Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 35781-0210
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: 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.
Updated December 1, 2011
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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.Close
- 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
Stimulates healing of injured
tissues, wounds, contusions,
hematomas, neuralgia, myalgia,
Inflammation and gout
healing of tissues
Narrow leaf cone flower
Inflammation and inhibits
Purple cone flower
Astringent, analgesic, hematomas
St. John’s wort
Hematomas, wound healing
- 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.Close
Known sensitivity to Arnica Montana or any other ingredient.Close
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.Close
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.Close
- ADVERSE REACTIONS
Rarely, allergic skin reactions may occur. If allergic reactions occur, discontinue use of the drug.Close
- 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
- INGREDIENTS AND APPEARANCE
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:50436-9072(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:50436-9072-1 1 in 1 CARTON 1 30 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2011 Labeler - Unit Dose Services (831995316) Registrant - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK