TRAUMEEL - calendula officinalis flowering top and hamamelis virginiana root bark/stem bark and arnica montana root and aconitum napellus and atropa belladonna and bellis perennis and matricaria recutita and echinacea, unspecified and echinacea purpurea and achillea millefolium and calcium sulfide and mercurius solubilis and comfrey root and hypericum perforatum and gel 
MediNatura Inc

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.

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Traumeel 50g Gel

ACTIVE INGREDIENTS

Active ingredients: Each 50 g of gel contains: Calendula officinalis 1X, Hamamelis virginiana 1X, Arnica montana, radix 3X 0.75 g each; Aconitum napellus 3X, Belladonna 3X 0.50 g each; Bellis perennis 1X, Chamomilla 1X, Echinacea 1X, Echinacea purpurea 1X 0.25 g each; Millefolium 1X 0.15 g; Hepar sulphuris calcareum 8X 0.125 g; Mercurius solubilis 8X 0.06g; Symphytum officinale 4X 0.05 g Hypericum perforatum 6X 0.045 g.

PURPOSE

Calendula officinalis 1X 0.75 g....................Stimulates healing process

Hamamelis virginiana 1X 0.75 g.................Relieves bruised soreness

Arnica montana, radix 3X 0.75 g.................Reduces bruising

Aconitum napellus 3X 0.5 g........................Reduces pain after injury

Belladonna 3X 0.50 g.................................Reduces pain

Bellis perennis 1X 0.25 g............................Treats bruises

Chamomilla 1X 0.25 g................................Soothing pain relief

Echinacea 1X 0.25 g..................................Immune support

Echinacea purpurea 1X 0.25 g....................Stimulates healing process

Millefolium 1X 0.15 g.................................Treats minor bleeding

Hepar sulphuris calcareum 8X 0.125 g.........Stimulates injury healing

Mercurius solubilis 8X 0.06g.......................Reduces joint pain

Symphytum officinale 4X 0.05 g..................Relieves joint pain

Hypericum perforatum 6X 0.045 g...............Relieves pain

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

Indications: For the temporary relief of muscular pain, joint pain, sports injuries and bruising.

WARNINGS

Warnings: For external use only. Do not apply over large areas of the body. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a physician should be consulted. In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traumeel or any of its ingredients exists.

DOSAGE AND ADMINISTRATION

Directions: Adults, children and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Rub gently into the skin. Traumeel may be applied using mild compression bandaging and/or occlusive bandaging.

INACTIVE INGREDIENTS

Traumeel 50g Gel Carton.jpg
TRAUMEEL  
calendula officinalis flowering top and hamamelis virginiana root bark/stem bark and arnica montana root and aconitum napellus and atropa belladonna and bellis perennis and matricaria recutita and echinacea, unspecified and echinacea purpurea and achillea millefolium and calcium sulfide and mercurius solubilis and comfrey root and hypericum perforatum and gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-8010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 50 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 50 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 50 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 50 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 50 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 50 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 [hp_X]  in 50 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 [hp_X]  in 50 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 50 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 50 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 50 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]  in 50 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT4 [hp_X]  in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 50 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8010-31 in 1 CARTON10/31/199909/30/2014
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/31/199909/30/2014
Labeler - MediNatura Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
MediNatura Inc102783016pack(50114-8010)

Revised: 2/2017
 
MediNatura Inc