TRAUMEEL X- 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 
Biologische Heilmittel Heel

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 Ointment

ACTIVE INGREDIENTS

Active ingredients: Each 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

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

Keep out of reach of children.

INDICATIONS AND USAGE

For the temporary relief of minor:

  • Joint Pain
  • Back Pain
  • Muscular Pain

WARNINGS

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

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

INACTIVE INGREDIENTS

Inactive ingredients:Cetylstearyl alcohol, Ethanol, Parafin, Purified water, White petrolatum

Traumeel X Ointment v.2.jpg

TRAUMEEL X 
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
Product TypeHUMAN OTC DRUGItem 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51885-7125-350 g in 1 CARTON; Type 0: Not a Combination Product05/24/201204/30/2014
2NDC:51885-7125-1100 g in 1 CARTON; Type 0: Not a Combination Product05/24/201204/30/2014
3NDC:51885-7125-64 g in 1 POUCH; Type 0: Not a Combination Product04/30/201404/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/24/201204/30/2014
Labeler - Biologische Heilmittel Heel (315635359)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(51885-7125)

Revised: 5/2018
 
Biologische Heilmittel Heel