Label: TRAUMEEL COMBO PACK - traumeel   

  • NDC Code(s): 50114-6150-2, 50114-8502-2, 51885-3302-3
  • Packager: Heel Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Traumeel Tablet:


    Each 300 mg tablet contains as active ingredients: Aconitum napellus 3X 30 mg; Arnica montana, radix 3X 40 mg; Belladonna 4X 75 mg; Bellis perennis 2X 6 mg; Calendula officinalis 2X 15 mg; Chamomilla 3X 24 mg; Echinacea 2X 6 mg; Echinacea purpurea 2X 6 mg; Hamamelis virginiana 2X 15 mg; Hepar sulphuris calcareum 8X 15 mg; Hypericum perforatum 3X 8 mg; Mercurius solubilis 8X 15 mg; Millefolium 3X 15 mg; Symphytum officinale 8X 24 mg.


    Traumeel Ointment:

    Each 50g of ointment contains: Calendula officinalis 1X, Hamamelis virginiana 1X, Arnica montana, radix 3X 0.75 g each; Aconitum napellus 3X, Belladonna 3X 0.5 g each; Bellis perennis 1X, Chamomilla 1X, Echinacea 1X, Echinacea purpurea 1X 0.25 g each; Millefolium 1X 0.15 g; Hepar sulphuris calcareum 8X 0.125 g; Mercurius solubilis 8X 0.06g; Symphytum officinale 4X 0.05 g Hypericum perforatum 6X 0.045 g.
    Close
  • PURPOSE

    Traumeel Tablet:

    Aconitum napellus 3X 30 mg.................Reduces pain after injury
    Arnica montana, radix 3X 40 mg............Reduces pain due to bruises
    Belladonna 4X 75 mg............................Reduces pain
    Bellis perennis 2X 6 mg........................Reduces pain due to bruises
    Calendula officinalis 2X 15 mg..............Stimulates healing process
    Chamomilla 3X 24 mg..........................Soothing pain relief
    Echinacea 2X 6 mg..............................Immune support
    Echinacea purpurea 2X 6 mg................Stimulates healing process
    Hamamelis virginiana 2X 15 mg............Relieves bruised soreness
    Hepar sulphuris calcareum 8X 15 mg....Stimulates injury healing
    Hypericum perforatum 3X 8 mg.............Relieves pain
    Mercurius solubilis 8X 15 mg................Reduces joint pain
    Millefolium 3X 15 mg...........................Treats minor bleeding
    Symphytum officinale 8X 24 mg...........Relieves joint pain

    Traumeel Ointment:

    Calendula officinalis 1X 1.5 g....................Stimulates healing process
    Hamamelis virginiana 1X  1.5 g.................Relieves bruised soreness
    Arnica montana, radix 3X 1.5 g.................Reduces bruising
    Aconitum napellus 3X 1 g.........................Reduces pain after injury
    Belladonna 3X 1 g....................................Reduces pain
    Bellis perennis 1X 0.5 g............................Treats bruises
    Chamomilla 1X 0.5 g................................Soothing pain relief
    Echinacea 1X 0.5 g..................................Immune support
    Echinacea purpurea 1X 0.5 g....................Stimulates healing process
    Millefolium 1X 0.3 g.................................Treats minor bleeding
    Hepar sulphuris calcareum 8X 0.25 g........Stimulates injury healing
    Mercurius solubilis 8X 0.12 g....................Reduces joint pain
    Symphytum officinale 4X 0.1 g..................Relieves joint pain
    Hypericum perforatum 6X 0.09 g...............Relieves pain
    Close
  • KEEP OUT OF REACH OF CHILDREN

    Traumeel Tablets:

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

    Traumeel Ointment:

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

    Close
  • INDICATIONS AND USAGE

    Traumeel Tablets:

    For the temporary relief of pain due to:

    • Muscular pain
    • Joint pain
    • Sports injuries
    • Bruising

    Traumeel Ointment:

    For the temporary relief of muscular pain, joint pain, sports injuries and bruising.


    Close
  • WARNINGS

    Traumeel Tablets:

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


    Traumeel Ointment:

    For external use only. Do not apply over large areas of the body. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a physician 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.
    Close
  • DOSAGE AND ADMINISTRATION

    Traumeel Tablets:

    Adults and children above 6 years: 1 tablet 3 times daily or as directed by a physician. Infants and children to 6 years: 1/2 the adult dosage.
    Place tablet under the tongue or in mouth and completely dissolve.

    Traumeel Ointment:

    Adults, children and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Rub gently into the skin. Traumeel may be applied using mild compression bandaging and/or occlusive bandaging.
    Close
  • INACTIVE INGREDIENTS

    Traumeel Tablets:

    Lactose, Magnesium stearate


    Traumeel Ointment:

    Cetylstearyl alcohol, Ethanol, Parafin, Purified water, White petrolatum
    Close
  • INGREDIENTS AND APPEARANCE
    TRAUMEEL COMBO PACK 
    traumeel kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50114-8502
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-8502-2 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 100 
    Part 2 1 TUBE 50 g
    Part 1 of 2
    TRAUMEEL 
    aconitum napellus and arnica montana root and atropa belladonna and bellis perennis and calendula officinalis flowering top and chamomile 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 tablet
    Product Information
    Item Code (Source) NDC:50114-6150
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]
    ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 3 [hp_X]
    ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 4 [hp_X]
    BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 2 [hp_X]
    CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X]
    CHAMOMILE (CHAMOMILE) CHAMOMILE 3 [hp_X]
    ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 2 [hp_X]
    ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 2 [hp_X]
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X]
    CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 8 [hp_X]
    HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 3 [hp_X]
    MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 8 [hp_X]
    ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 3 [hp_X]
    COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 8 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white (Tablet) Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code Heel
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-6150-2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/31/1984
    Part 2 of 2
    TRAUMEEL 
    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
    Item Code (Source) NDC:51885-3302
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]  in 100 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]  in 100 g
    ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 3 [hp_X]  in 100 g
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]  in 100 g
    ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 3 [hp_X]  in 100 g
    BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 1 [hp_X]  in 100 g
    MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 1 [hp_X]  in 100 g
    ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 1 [hp_X]  in 100 g
    ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 1 [hp_X]  in 100 g
    ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 1 [hp_X]  in 100 g
    CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 8 [hp_X]  in 100 g
    MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 8 [hp_X]  in 100 g
    COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 4 [hp_X]  in 100 g
    HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 6 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETOSTEARYL ALCOHOL  
    ALCOHOL  
    WATER  
    PETROLATUM  
    PARAFFIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51885-3302-3 1 in 1 CARTON
    1 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/31/1986
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/31/2012
    Labeler - Heel Inc (102783016)
    Establishment
    Name Address ID/FEI Business Operations
    Heel Inc 102783016 manufacture(50114-6150)
    Establishment
    Name Address ID/FEI Business Operations
    Biologische Heilmittel Heel 315635359 manufacture(51885-3302)
    Close