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Traumeel

Heel Inc

Traumeel Ear Drops Rx


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TRAUMEEL DESCRIPTION

Active Ingredients Inactive Ingredients

TRAUMEEL INDICATIONS AND USAGE


TRAUMEEL DOSAGE AND ADMINISTRATION

Adults and children 6 years and over:Infants and children under 6 years:

WARNINGS AND PRECAUTIONS



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
Traumeel

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 Type Human prescription drug label Item Code (Source) NDC:50114-7110
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARNICA MONTANA ROOT ARNICA MONTANA ROOT 3 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 3 [hp_X]
ACONITUM NAPELLUS ACONITUM NAPELLUS 3 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
ACHILLEA MILLEFOLIUM 3 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 6 [hp_X]
COMFREY ROOT COMFREY ROOT 6 [hp_X]
BELLIS PERENNIS Bellis Perennis 2 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 6 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 2 [hp_X]
ECHINACEA PURPUREA 2 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.45 in 1 VIAL, SINGLE-DOSE
2 NDC:50114-7110-1 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2002-09-30


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