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

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

If pregnant or breast-feeding, ask a healthcare provider before use. Keep out of reach of children. 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.

DOSAGE AND ADMINISTRATION

Standard Dosage:

Adults and children 12 years and older: 30 drops per day, taking 10 drops every 4 to 6 hours.

Children under 12 years: Consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: 10 drops every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceeed 120 drops in 24 hours.

Children under 12 years: Consult your healthcare provider.

If used in children below 18 years for more than 14 days, contact a healthcare provider as these drops contain alcohol.

ACTIVE INGREDIENTS

Each 10 drops 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

INACTIVE INGREDIENTS

Ethanol, Purified Water

PURPOSE

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 OD v.3.jpg

TRAUMEEL 
aconitum napellus, arnica montana root, atropa belladonna, bellis perennis, calendula officinalis flowering top, matricaria recutita, echinacea, unspecified, echinacea purpurea, hamamelis virginiana root bark/stem bark, calcium sulfide, hypericum perforatum, mercurius solubilis, achillea millefolium and comfrey root liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-1160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS3 [hp_X]  in 50 mL
ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT3 [hp_X]  in 50 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA4 [hp_X]  in 50 mL
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS2 [hp_X]  in 50 mL
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]  in 50 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA3 [hp_X]  in 50 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED2 [hp_X]  in 50 mL
ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA2 [hp_X]  in 50 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]  in 50 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE8 [hp_X]  in 50 mL
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM3 [hp_X]  in 50 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS8 [hp_X]  in 50 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM3 [hp_X]  in 50 mL
COMFREY ROOT (COMFREY ROOT) COMFREY ROOT8 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1160-41 in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/198608/20/2014
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Inc102783016manufacture(50114-1160)

Revised: 8/2014
Document Id: ff61bf22-4d7a-4e90-8fcf-ba0fb8242d3c
Set id: 9c5c1a16-035f-401b-8bfe-2958604450dd
Version: 4
Effective Time: 20140821
 
Heel Inc