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 gel 
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 X Gel 250g

ACTIVE INGREDIENTS

Active ingredients: Each 250g 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

Joint pain, Back pain, Muscular pain

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIOS

For the temporary relief of

WARNINGS

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

Directions: 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

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



Traumeel X 250 g Gel v.2

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 gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-8130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP1 g  in 250 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 g  in 250 g
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]  in 250 g
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS1 [hp_X]  in 250 g
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA1 [hp_X]  in 250 g
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS1 g  in 250 g
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA1 g  in 250 g
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED1 g  in 250 g
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA1 g  in 250 g
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM1 g  in 250 g
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE6 [hp_X]  in 250 g
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS6 [hp_X]  in 250 g
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT4 [hp_X]  in 250 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM6 [hp_X]  in 250 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
ALCOHOL 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-8130-4250 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/13/201308/20/2014
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-8130)

Revised: 8/2014
Document Id: 86ee945b-d9c5-4eee-8342-a27180086442
Set id: b8615128-af19-4fec-922f-42f10b389dcf
Version: 4
Effective Time: 20140826
 
Heel Inc