Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID d8610c75-2d98-4810-8265-96f8f151b61f
Route
ORAL
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (3 [hp_X]) Echinacea Angustifolia (4 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark (6 [hp_X]) Hypericum Perforatum (8 [hp_X]) Achillea Millefolium (12 [hp_X]) Calendula Officinalis Flowering Top Arnica Montana Bellis Perennis Toxicodendron Pubescens Leaf Bryonia Alba Root Clematis Vitalba Pre-flowering Top Calcium Sulfide Ornithogalum Umbellatum Prunus Cerasifera Flower Activated Charcoal
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-08-22

Description

Arnica Montana 4X, 12X, 30X, 200X, Bellis Perennis 6X, Bryonia (Alba) 8X, Calendula Officinalis 4X, Carbo Vegetabilis 12X, Chamomilla 3X, Clematis Vitalba, Folia 8X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Rhus Tox 6X, 12X, 30X.

Purpose

Arnica Montana – Trauma Following Surgery, Bellis Perennis - Injuries, Bryonia (Alba) - Bruises, Calendula Officinalis - Contusions, Carbo Vegetabilis - Lesions, Chamomilla - Sprains, Clematis Vitalba, Folia - Lesions, Echinacea (Angustifolia) – Trauma Following Surgery, Hamamelis Virginiana - Injuries, Hepar Sulphuris Calcareum - Bruises, Hypericum Perforatum - Contusions, Millefolium - Lesions, Ornithogalum Umbellatum – Trauma Following Surgery, Prunus Cerasifera, Flos - Lesions, Rhus Tox - Bruises


Medication Information

Purpose

Arnica Montana – Trauma Following Surgery, Bellis Perennis - Injuries, Bryonia (Alba) - Bruises, Calendula Officinalis - Contusions, Carbo Vegetabilis - Lesions, Chamomilla - Sprains, Clematis Vitalba, Folia - Lesions, Echinacea (Angustifolia) – Trauma Following Surgery, Hamamelis Virginiana - Injuries, Hepar Sulphuris Calcareum - Bruises, Hypericum Perforatum - Contusions, Millefolium - Lesions, Ornithogalum Umbellatum – Trauma Following Surgery, Prunus Cerasifera, Flos - Lesions, Rhus Tox - Bruises

Description

Arnica Montana 4X, 12X, 30X, 200X, Bellis Perennis 6X, Bryonia (Alba) 8X, Calendula Officinalis 4X, Carbo Vegetabilis 12X, Chamomilla 3X, Clematis Vitalba, Folia 8X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Rhus Tox 6X, 12X, 30X.

Uses:

• For the temporary relief of symptoms including:

• Injuries • Bruises • Contusions • Lesions

• Sprains • Trauma Following Surgery

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose:

Arnica Montana – Trauma Following Surgery, Bellis Perennis - Injuries, Bryonia (Alba) - Bruises, Calendula Officinalis - Contusions, Carbo Vegetabilis - Lesions, Chamomilla - Sprains, Clematis Vitalba, Folia - Lesions, Echinacea (Angustifolia) – Trauma Following Surgery, Hamamelis Virginiana - Injuries, Hepar Sulphuris Calcareum - Bruises, Hypericum Perforatum - Contusions, Millefolium - Lesions, Ornithogalum Umbellatum – Trauma Following Surgery, Prunus Cerasifera, Flos - Lesions, Rhus Tox - Bruises

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients:

Arnica Montana 4X, 12X, 30X, 200X, Bellis Perennis 6X, Bryonia (Alba) 8X, Calendula Officinalis 4X, Carbo Vegetabilis 12X, Chamomilla 3X, Clematis Vitalba, Folia 8X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Rhus Tox 6X, 12X, 30X.

Inactive Ingredients:

Demineralized water, 25% ethanol

Package Label Display:

Des Bio

Trauma

Remedy

Homeopathic

NDC 43742-1536-1

1 FL OZ (30 ml)

Keep Out of Reach of Children:

In case of overdose, contact a physician or Poison Control Center right away.


Structured Label Content

Uses: (USES:)

• For the temporary relief of symptoms including:

• Injuries • Bruises • Contusions • Lesions

• Sprains • Trauma Following Surgery

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Purpose: (PURPOSE:)

Arnica Montana – Trauma Following Surgery, Bellis Perennis - Injuries, Bryonia (Alba) - Bruises, Calendula Officinalis - Contusions, Carbo Vegetabilis - Lesions, Chamomilla - Sprains, Clematis Vitalba, Folia - Lesions, Echinacea (Angustifolia) – Trauma Following Surgery, Hamamelis Virginiana - Injuries, Hepar Sulphuris Calcareum - Bruises, Hypericum Perforatum - Contusions, Millefolium - Lesions, Ornithogalum Umbellatum – Trauma Following Surgery, Prunus Cerasifera, Flos - Lesions, Rhus Tox - Bruises

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

800-827-8204

Directions: (DIRECTIONS:)

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 4X, 12X, 30X, 200X, Bellis Perennis 6X, Bryonia (Alba) 8X, Calendula Officinalis 4X, Carbo Vegetabilis 12X, Chamomilla 3X, Clematis Vitalba, Folia 8X, Echinacea (Angustifolia) 3X, Hamamelis Virginiana 3X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 3X, Millefolium 3X, 6X, Ornithogalum Umbellatum 8X, Prunus Cerasifera, Flos 8X, Rhus Tox 6X, 12X, 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

Des Bio

Trauma

Remedy

Homeopathic

NDC 43742-1536-1

1 FL OZ (30 ml)

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

In case of overdose, contact a physician or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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