TRAUMEEL COMBO PACK - traumeel   
Heel 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 Combo Pack

ACTIVE INGREDIENTS

Traumeel Tablet:


Each 300 mg tablet contains as active ingredients: Aconitum napellus 3X 30 mg; Arnica montana, radix 3X 40 mg; Belladonna 4X 75 mg; Bellis perennis 2X 6 mg; Calendula officinalis 2X 15 mg; Chamomilla 3X 24 mg; Echinacea 2X 6 mg; Echinacea purpurea 2X 6 mg; Hamamelis virginiana 2X 15 mg; Hepar sulphuris calcareum 8X 15 mg; Hypericum perforatum 3X 8 mg; Mercurius solubilis 8X 15 mg; Millefolium 3X 15 mg; Symphytum officinale 8X 24 mg.


Traumeel Ointment:

Each 50g of ointment contains: Calendula officinalis 1X, Hamamelis virginiana 1X, Arnica montana, radix 3X 0.75 g each; Aconitum napellus 3X, Belladonna 3X 0.5 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

Traumeel Tablet:

Aconitum napellus 3X 30 mg.................Reduces pain after injury
Arnica montana, radix 3X 40 mg............Reduces pain due to bruises
Belladonna 4X 75 mg............................Reduces pain
Bellis perennis 2X 6 mg........................Reduces pain due to bruises
Calendula officinalis 2X 15 mg..............Stimulates healing process
Chamomilla 3X 24 mg..........................Soothing pain relief
Echinacea 2X 6 mg..............................Immune support
Echinacea purpurea 2X 6 mg................Stimulates healing process
Hamamelis virginiana 2X 15 mg............Relieves bruised soreness
Hepar sulphuris calcareum 8X 15 mg....Stimulates injury healing
Hypericum perforatum 3X 8 mg.............Relieves pain
Mercurius solubilis 8X 15 mg................Reduces joint pain
Millefolium 3X 15 mg...........................Treats minor bleeding
Symphytum officinale 8X 24 mg...........Relieves joint pain

Traumeel Ointment:

Calendula officinalis 1X 1.5 g....................Stimulates healing process
Hamamelis virginiana 1X  1.5 g.................Relieves bruised soreness
Arnica montana, radix 3X 1.5 g.................Reduces bruising
Aconitum napellus 3X 1 g.........................Reduces pain after injury
Belladonna 3X 1 g....................................Reduces pain
Bellis perennis 1X 0.5 g............................Treats bruises
Chamomilla 1X 0.5 g................................Soothing pain relief
Echinacea 1X 0.5 g..................................Immune support
Echinacea purpurea 1X 0.5 g....................Stimulates healing process
Millefolium 1X 0.3 g.................................Treats minor bleeding
Hepar sulphuris calcareum 8X 0.25 g........Stimulates injury healing
Mercurius solubilis 8X 0.12 g....................Reduces joint pain
Symphytum officinale 4X 0.1 g..................Relieves joint pain
Hypericum perforatum 6X 0.09 g...............Relieves pain

KEEP OUT OF REACH OF CHILDREN

Traumeel Tablets:

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

Traumeel Ointment:

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

INDICATIONS AND USAGE

Traumeel Tablets:

For the temporary relief of pain due to:


Traumeel Ointment:

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


WARNINGS

Traumeel Tablets:

If symptoms persist or worsen, a physician should be consulted. If pregnant or breast-feeding, ask a health care professional before use.


Traumeel Ointment:

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

Traumeel Tablets:

Adults and children above 6 years: 1 tablet 3 times daily or as directed by a physician. Infants and children to 6 years: 1/2 the adult dosage.
Place tablet under the tongue or in mouth and completely dissolve.

Traumeel Ointment:

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 Tablets:

Lactose, Magnesium stearate


Traumeel Ointment:

Cetylstearyl alcohol, Ethanol, Parafin, Purified water, White petrolatum

Traumeel Combo Pack.jpg




TRAUMEEL COMBO PACK 
traumeel kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-8502
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8502-21 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 
Part 21 TUBE 50 g
Part 1 of 2
TRAUMEEL 
aconitum napellus and arnica montana root and atropa belladonna and bellis perennis and calendula officinalis flowering top and chamomile and echinacea, unspecified and echinacea purpurea and hamamelis virginiana root bark/stem bark and calcium sulfide and hypericum perforatum and mercurius solubilis and achillea millefolium and comfrey root tablet
Product Information
Item Code (Source)NDC:50114-6150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS3 [hp_X]
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA4 [hp_X]
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]
CHAMOMILE (CHAMOMILE) CHAMOMILE3 [hp_X]
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED2 [hp_X]
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA2 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE8 [hp_X]
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM3 [hp_X]
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS8 [hp_X]
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM3 [hp_X]
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (Tablet) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code Heel
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-6150-2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/1984
Part 2 of 2
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 ointment
Product Information
Item Code (Source)NDC:51885-3302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 100 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 100 g
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]  in 100 g
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS3 [hp_X]  in 100 g
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA3 [hp_X]  in 100 g
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS1 [hp_X]  in 100 g
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA1 [hp_X]  in 100 g
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED1 [hp_X]  in 100 g
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA1 [hp_X]  in 100 g
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM1 [hp_X]  in 100 g
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE8 [hp_X]  in 100 g
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS8 [hp_X]  in 100 g
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT4 [hp_X]  in 100 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM6 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
ALCOHOL 
WATER 
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51885-3302-31 in 1 CARTON
150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/31/1986
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/31/2012
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Inc102783016manufacture(50114-6150)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(51885-3302)

Revised: 5/2012
Document Id: c9019302-7070-4f1d-a9a3-e1a226b751ab
Set id: 817504a4-52cd-427b-87e8-f6dfcf1bb934
Version: 1
Effective Time: 20120518
 
Heel Inc