Label: 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/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated May 23, 2012

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  • DESCRIPTION

    Traumeel Ear Drops Rx is a liquid homeopathic drug for otic administration. Each 0.45 ml vial contains Active Ingredients: Arnica montana, radix 3X 9.9 mcl, Belladonna 3X 9.9 mcl, Aconitum napellus 3X 9.54 mcl, Hypericum perforatum 3X 2.97 mcl, Calendula officinalis 2X 0.99 mcl, Chamomilla 3X 0.99 mcl, Millefolium 3X 0.99 mcl, Hepar sulphuris calcareum 6X 0.99 mcl, Symphytum officinale 6X 0.99 mcl, Bellis perennis 2X 0.495 mcl, Mercurius solubilis 6X 0.495 mcl, Echinacea 2X 0.247 mcl, Echinacea purpurea 2X 0.247 mcl, Hamamellis virginiana 1X 0.099 mcl Inactive Ingredients: Isotonic Sodium Chloride Solution.
  • INDICATIONS AND USAGE

    Traumeel Ear Drops Rx is indicated for the treatment of pain due to inflammation of otitis media and externa.
  • DOSAGE AND ADMINISTRATION

    Adults and children 6 years and over: pour contents of 1 vial directly into the affected ear up to 3 times daily. Infants and children under 6 years: pour 1/2 of the contents of 1 vial into the affected ear up to 3 times daily.
  • WARNINGS AND PRECAUTIONS

    No harmful or potentially harmful side effects are known. Traumeel ear drops is generally well-tolerated, however if symptoms persist or worsen, discontinue use.

    To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • PRINCIPAL DISPLAY PANEL

    Traumeel Ear Drops Rx.jpg


  • INGREDIENTS AND APPEARANCE
    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/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-7110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]  in 0.45 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 0.45 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 0.45 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 0.45 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]  in 0.45 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 0.45 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM3 [hp_X]  in 0.45 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB, SULFIDE ION - UNII:G15I91XETI) CALCIUM SULFIDE6 [hp_X]  in 0.45 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 0.45 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS2 [hp_X]  in 0.45 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS6 [hp_X]  in 0.45 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED2 [hp_X]  in 0.45 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]  in 0.45 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 0.45 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-7110-110 in 1 CARTON
    10.45 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/30/2002
    Labeler - Heel Inc (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holopack-Verpackungstechnik-GmbH313222457manufacture
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