TRAUMEEL X VALUE PACK- traumeel 
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 X Value Pack

ACTIVE INGREDIENTS

Traumeel Tablet:

Each tablet contains as active ingredients: Aconitum napellus 3X, Arnica montana, radix 3X, Belladonna 4X, Bellis perennis 2X, Calendula officinalis 2X, Chamomilla 3X, Echinacea 2X, Echinacea purpurea 2X, Hamamelis virginiana 2X, Hepar sulphuris calcareum 8X, Hypericum perforatum 3X,Mercurius solubilis 8X, Millefolium 3X, Symphytum officinale 8X

Traumeel Ointment:
Each 50g ointment contains: Aconitum napellus 1X, Arnica montana 3X, Belladonna 1X, Bellis perennis MT (M), Calendula officinalis MT (N), Chamomilla MT (N), Echinacea MT (N), Echinacea purpurea MT (N), Hamamelis virginiana MT (N), Hepar sulphuris calcareum 6X, Hypericum perforatum 6X, Mercurius solubilis 6X, Millefolium MT (N), Symphytum officinale 4X

PURPOSE

Traumeel Tablet:

Aconitum napellus 3X............................. Reduces joint and back pain

Arnica montana, radix 3X........................ Reduces joint and back pain

Belladonna 4X......................................................Reduces back pain

Bellis perennis 2X........................Relieves joint and muscle soreness

Calendula officinalis 2X................................................. Relieves pain

Chamomilla 3X.....................................................Soothing pain relief

Echinacea 2X............................................................... Relieves pain

Echinacea purpurea 2X................................................. Relieves pain

Hamamelis virginiana 2X.............. Relieves joint and muscle soreness

Hepar sulphuris calcareum 8X...................................... Relieves pain

Hypericum perforatum 3X..............................................Relieves pain

Mercurius solubilis 8X............................. Reduces joint and back pain

Millefolium 3X...............................................................Relieves pain

Symphytum officinale 8X....................................... Relieves joint pain


Traumeel Ointment:

Aconitum napellus 1X...........................Reduces joint and back pain

Arnica montana 3X ..............................Reduces joint and back pain

Belladonna 1X.....................................................Reduces back pain

Bellis perennis MT (M)..................Relieves joint and muscle soreness

Calendula officinalis MT (N)..........................................Relieves pain

Chamomilla MT (N)............................................Soothing pain relief

Echinacea MT (N).......................................................Relieves pain

Echinacea purpurea MT (N)..........................................Relieves pain

Hamamelis virginiana MT (N)......Relieves joint and muscle soreness

Hepar sulphuris calcareum 6X......................................Relieves pain

Hypericum perforatum 6X...........................................Relieves pain

Mercurius solubilis 6X...........................Reduces joint and back pain

Millefolium MT (N).......................................................Relieves pain

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

KEEP OUT OF REACH OF CHILDREN

Traumeel Tablets: 

Keep out of reach of children.


Traumeel Ointment:

Keep out of reach of children.

INDICATIONS AND USAGE

Traumeel Tablets:

For the temporary relief of minor:

  • Joint Pain
  • Back Pain
  • Muscular Pain

Traumeel Ointment:

For the temporary relief of minor:

  • Joint Pain
  • Back Pain
  • Muscular Pain

WARNINGS

Traumeel Tablets:

If symptoms persist or worsen, a healthcare provider should be consulted. Do not use if known sensitivity to Traumeel® or any of its ingredients exists. Keep out of reach of children.If pregnant or breast-feeding, ask a healthcare provider before use.


Traumeel Ointment:

For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a healthcare provider 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a healthcare provider before use.

DOSAGE AND ADMINISTRATION

Traumeel Tablets:

Standard Dosage:

Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

Children 4 to 11 years: 2 tablets per day, taking 1 tablet every 6 to 8 hours.

Children under 4 years: Consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: 1 tablet every ½ to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

Children 4 to 11 years: 1 tablet every ½ to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours.

Children under 4 years, consult your healthcare provider.

Allow tablets to dissolve completely in the mouth, do not swallow.


Traumeel Ointment:

Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. For children under 4, consult your healthcare provider.

INACTIVE INGREDIENTS

Traumeel Tablets:


Lactose, Magnesium stearate


Traumeel Ointment:


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

Traumeel X Value Pack v.2.jpg

TRAUMEEL X VALUE PACK 
traumeel kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-8505
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8505-21 in 1 KIT08/12/201309/30/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 100 
Part 21 TUBE 50 g
Part 1 of 2
TRAUMEEL 
aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, chamomile, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, 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
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code Heel
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-6150-6100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/1984
Part 2 of 2
TRAUMEEL X 
calendula officinalis flowering top, hamamelis virginiana root bark/stem bark, arnica montana root, aconitum napellus, atropa belladonna, bellis perennis, matricaria recutita, echinacea, unspecified, echinacea purpurea, achillea millefolium, calcium sulfide, mercurius solubilis, comfrey root and hypericum perforatum ointment
Product Information
Item Code (Source)NDC:51885-7125
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 g  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 g  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 NAPELLUS1 [hp_X]  in 50 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA1 [hp_X]  in 50 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 g  in 50 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 g  in 50 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED1 g  in 50 g
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 g  in 50 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 g  in 50 g
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 50 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS6 [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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51885-7125-350 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/201309/30/2014
Labeler - MediNatura Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Medinatura Inc102783016manufacture(50114-6150)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(51885-7125)

Revised: 1/2017
 
MediNatura Inc