TRAUMEEL X- aconitum napellus and arnica montana root and atropa belladonna and bellis perennis and calendula officinalis flowering top and matricaria recutita 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 gel 
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 Gel 50g

ACTIVE INGREDIENTS

Active ingredients: Each 50g contains: Aconitum napellus 1X (Final concentration 4X), Arnica montana, radix, 3X, Belladonna 1X, Bellis perennis MT, Calendula officinalis MT, Chamomilla MT, Echinacea MT, Echinacea purpurea MT, Hamamelis virginiana MT, Hepar sulphuris calcareum 6X, Hypericum perforatum 6X, Mercurius solubilis 6X, Millefolium MT,Symphytum officinale 4X.

PURPOSE

Aconitum napellus 1X (Final Concentration 4X)......................Reduces joint and back pain
Arnica montana, radix 3X.....................Reduces joint and back pain
Belladonna 1X....................................Reduces back pain
Bellis perennis MT ..............................Relieves joint and muscle soreness
Calendula officinalis MT .......................Relieves pain
Chamomilla MT ..................................Soothing pain relief
Echinacea MT......................................Relieves pain
Echinacea purpurea MT.........................Relieves pain
Hamamelis virginiana MT......................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.....................................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 professional 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.

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:Carbopol 980, ethanol, purified water and sodium hydroxide.

Traumeel X 50g Gel v.3.jpg

TRAUMEEL X 
aconitum napellus and arnica montana root and atropa belladonna and bellis perennis and calendula officinalis flowering top and matricaria recutita 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 gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51885-8130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS1 [hp_X]  in 50 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [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
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 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
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
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 50 g
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS6 [hp_X]  in 50 g
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 g  in 50 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT4 [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:51885-8130-350 g in 1 CARTON; Type 0: Not a Combination Product02/15/201309/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/15/201309/30/2014
Labeler - Biologische Heilmittel Heel (315635359)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(51885-8130)

Revised: 1/2017
 
Biologische Heilmittel Heel