Traumeel Ointment

Traumeel Ointment
SPL v3
SPL
SPL Set ID c9962e63-3c30-4c62-9caf-91f663c7eeaa
Route
TOPICAL
Published
Effective Date 2023-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (1 [hp_X]) Arnica Montana Root (3 [hp_X]) Atropa Belladonna (6 [hp_X]) Bellis Perennis (4 [hp_X]) Calendula Officinalis Flowering Top Matricaria Chamomilla Echinacea, Unspecified Echinacea Purpurea Hamamelis Virginiana Root Bark/stem Bark Calcium Sulfide Hypericum Perforatum Mercurius Solubilis Achillea Millefolium Comfrey Root
Inactive Ingredients
Cetostearyl Alcohol Alcohol Water Paraffin Mineral Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-14

Description

Active ingredients: Each 100 g contains: *Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g. *Natural Ingredients

Purpose

Analgesic


Medication Information

Purpose

Analgesic

Description

Active ingredients: Each 100 g contains: *Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g. *Natural Ingredients

Section 51945-4

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Warning

Warnings: For external use only. Cetylstearyl alcohol may cause local skin reactions, i.e.

contact dermatitis. 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.

Do not use if known sensitivity to Traumeel® ointment 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 health professional before use.

Store at room temperature. Protect from light.

Please retain outer carton for full product instructions.

WARNING: This product can expose you to mercury, which is known to

the State of California to cause birth defects or other reproductive harm.

For more information go to www.P65Warnings.ca.gov.

Directions

Directions: Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or as directed

by your health professional. Massage thoroughly into skin. Traumeel® may be applied using mild compression bandaging

and/or occlusive bandaging. For children under 4, use as directed by your health professional.

Indications

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

Active Ingredients

Active ingredients: Each 100 g contains:

*Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g.

*Natural Ingredients

Inactive Ingredients

Inactive ingredients:

Paraffin, liquid, Cetostearyl alcohol (type A), emulsifying, Paraffin, white soft, Ethanol (96 per cent)

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Section 51945-4 (51945-4)

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Purpose (PURPOSE)

Analgesic

Warning

Warnings: For external use only. Cetylstearyl alcohol may cause local skin reactions, i.e.

contact dermatitis. 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.

Do not use if known sensitivity to Traumeel® ointment 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 health professional before use.

Store at room temperature. Protect from light.

Please retain outer carton for full product instructions.

WARNING: This product can expose you to mercury, which is known to

the State of California to cause birth defects or other reproductive harm.

For more information go to www.P65Warnings.ca.gov.

Directions

Directions: Adults and children 4 years and older: Apply generously to affected areas 2 to 3 times daily, or as directed

by your health professional. Massage thoroughly into skin. Traumeel® may be applied using mild compression bandaging

and/or occlusive bandaging. For children under 4, use as directed by your health professional.

Indications

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

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients: Each 100 g contains:

*Aconitum napellus 1X 0.050g; *Arnica montana, radix 3X 1.50g; *Belladonna 1X 0.050g; *Bellis perennis MT 0.100g; *Calendula officinalis MT 0.450g; *Chamomilla MT 0.150g; *Echinacea MT 0.150g; *Echinacea purpurea MT 0.150g; *Hamamelis virginiana MT 0.450g; Hepar sulphuris calcareum 6X 0.025g; *Hypericum perforatum 6X 0.090g; Mercurius solubilis 6X 0.040g; *Millefolium MT 0.090g; *Symphytum officinale 4X 0.100g.

*Natural Ingredients

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients:

Paraffin, liquid, Cetostearyl alcohol (type A), emulsifying, Paraffin, white soft, Ethanol (96 per cent)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

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