TRAUMEEL- arnica montana root, atropa belladonna, aconitum napellus, hypericum perforatum, calendula officinalis flowering top, matricaria recutita, achillea millefolium, calcium sulfide, comfrey root, bellis perennis, mercurius solubilis, echinacea, unspecified, echinacea purpurea and hamamelis virginiana root bark/stem bark solution 
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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ACTIVE INGREDIENTS

Active ingredients: Each 2.2 ml contains as Active Ingredients: Arnica montana, radix 3X 22 mcl; Belladonna 3X 22 mcl; Aconitum napellus 3X 13.2 mcl; Hypericum perforatum 3X 6.6 mcl; Calendula officinalis 2X 2.2 mcl; Chamomilla 3X 2.2 mcl; Millefolium 3X 2.2 mcl; Hepar sulphuris calcareum 6X 2.2 mcl; Symphytum officinale 6X 2.2 mcl; Bellis perennis 2X 1.1 mcl; Mercurius solubilis 6X 1.1 mcl; Echinacea 2X 0.55 mcl; Echinacea purpurea 2X 0.55 mcl; Hamamelis virginiana 1X 0.22 mcl each.

INACTIVE INGREDIENTS

Inactive ingredients: Isotonic sodium chloride solution

PURPOSE

Minor Back, Joint and Muscle Pain

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

Indications: For the temporary relief of:

  • Minor Back, Joint and Muscle Pain

WARNINGS

Warnings: If symptoms persist or worsen, a health care professional should be consulted. If pregnant or breast feeding, ask a health care professional before use.

DOSAGE AND ADMINISTRATION

Dosage: Adults and children above 6 years: In general 1 vial orally 1 - 3 times daily, or as directed by a physician. Children up to 6 years: 1/2 vial orally 1 - 3 times daily, or as directed by a physician. Discard unused solution.

Traumeel Oral Vial.jpg

TRAUMEEL 
arnica montana root and atropa belladonna and aconitum napellus and hypericum perforatum and calendula officinalis flowering top and matricaria recutita and achillea millefolium and calcium sulfide and comfrey root and bellis perennis and mercurius solubilis and echinacea, unspecified and echinacea purpurea and hamamelis virginiana root bark/stem bark solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-1120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]  in 2.2 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA3 [hp_X]  in 2.2 mL
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS3 [hp_X]  in 2.2 mL
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM3 [hp_X]  in 2.2 mL
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]  in 2.2 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA3 [hp_X]  in 2.2 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM3 [hp_X]  in 2.2 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE6 [hp_X]  in 2.2 mL
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT6 [hp_X]  in 2.2 mL
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS2 [hp_X]  in 2.2 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS6 [hp_X]  in 2.2 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED2 [hp_X]  in 2.2 mL
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA2 [hp_X]  in 2.2 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 2.2 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1120-610 in 1 CARTON
12.2 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/199308/20/2014
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-1120)

Revised: 8/2014
Document Id: 8676f719-418a-4aa6-9287-847b227ab84b
Set id: 869ffe32-5695-4346-8816-3369e1c9ee62
Version: 2
Effective Time: 20140821
 
Heel Inc