Traumeel description, usages, side effects, indications, overdosage, supplying and lots more!

Traumeel

Biologische Heilmittel Heel

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Traumeel 50g Gel

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

Active ingredients:

PURPOSE















KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

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

WARNINGS

Warnings: 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.

DOSAGE AND ADMINISTRATION

Directions: 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.

INACTIVE INGREDIENTS

Inactive ingredients:

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:51885-3310
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 (ALLYL PENTAERYTHRITOL CROSSLINKED)
ALCOHOL
water
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 TUBE
2 NDC:51885-3310-3 1 in 1 CARTON

Marketing Information

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


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