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Traumeel

Heel Inc

Traumeel 250g Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Active ingredients: Each 250 g contains: Aconitum napellus 3X, Arnica montana, radix 3X, Belladonna 3X, Bellis perennis 1X, Calendula officinalis 1X, Chamomilla 1X, Echinacea 1X, Echinacea purpurea 1X, Hamamelis virginiana 1X, Hepar sulphuris calcareum 8X, Hypericum perforatum 6X, Mercurius solubilis 8X, Millefolium 1X, Symphytum officinale 4X.

PURPOSE

Joint Pain, Back Pain, Muscular Pain

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

TRAUMEEL INDICATIONS AND USAGE

WARNINGS

For external use only. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a healthcare provider 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a healthcare provider before use.

TRAUMEEL DOSAGE AND ADMINISTRATION

Directions: Adults and children 4 years and older: Apply generously to affected areas 2 - 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. For children under 4, consult your healthcare provider.

INACTIVE INGREDIENTS

Inactive ingredients:

Traumeel

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 GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50114-8015
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]
ARNICA MONTANA ROOT ARNICA MONTANA ROOT 3 [hp_X]
ACONITUM NAPELLUS ACONITUM NAPELLUS 3 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 3 [hp_X]
BELLIS PERENNIS Bellis Perennis 1 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 1 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 1 [hp_X]
ECHINACEA PURPUREA 1 [hp_X]
ACHILLEA MILLEFOLIUM 1 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 8 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 8 [hp_X]
COMFREY ROOT COMFREY ROOT 4 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 6 [hp_X]

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C
ALCOHOL
water
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50114-8015-4 250 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1999-10-31


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Be sure to consult your doctor before taking any medication!
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