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:Muscular painJoint painSports injuriesBruising

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 DRUGItem Code (Source)NDC:50114-8502
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8502-21 in 1 KIT05/31/201209/30/2014
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS2 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_X]
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED2 [hp_X]
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
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 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 100 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 100 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 100 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 100 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 100 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 100 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 [hp_X]  in 100 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 [hp_X]  in 100 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 100 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 100 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 100 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS8 [hp_X]  in 100 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT4 [hp_X]  in 100 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51885-3302-31 in 1 CARTON
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/31/201209/30/2014
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
MediNatura Inc102783016manufacture(50114-6150)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(51885-3302)

Revised: 2/2017
 
Heel Inc