Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 651f998a-c150-4f38-8582-b9bd97140910
Route
TOPICAL
Published
Effective Date 2024-10-22
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 Atropa Belladonna Bellis Perennis Helianthemum Nummularium Flower Impatiens Glandulifera Flower Ornithogalum Umbellatum Flowering Top Prunus Cerasifera Flower Comfrey Root Toxicodendron Pubescens Leaf Bryonia Alba Root Calcium Sulfide Activated Charcoal
Inactive Ingredients
Water Glycerin Arginine Sodium Pyrrolidone Carboxylate Aloe Vera Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Benzyl Alcohol Dehydroacetic Acid Glycine Aspartic Acid Hyaluronic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-12-07

Description

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

Purpose

For the temporary relief of strains, sprains, and joint pain.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.


Medication Information

Purpose

For the temporary relief of strains, sprains, and joint pain.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Description

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

Purpose:

For the temporary relief of strains, sprains, and joint pain.**

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

Warnings:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Do not use if seal is broken or missing.

For external use only, not for oral use.

Do not expose to extreme heat.

Questions:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

Indications:

For the temporary relief of strains, sprains, and joint pain.**

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

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, Glycerin, L-Arginine Base, Sodium Lactate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzylalcohol, Dehydroacetic Acid, Glycine, L-Aspartic Acid, Sodium Hyaluronate.

Package Label Display:

DESBIO

NDC 43742-1333-1

HOMEOPATHIC

TRAUMA

RELIEF GEL

With Aloe Vera

NET WT 4.44 OZ (126 G)

Suggested Application:

Apply a small amount on the area of discomfort, gently rubbing the gel into the skin. Application should be as soon after the injury as possible. Repeat three times in ten minute intervals; thereafter apply three times daily as needed.

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

For the temporary relief of strains, sprains, and joint pain.**

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

Warnings: (WARNINGS:)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Do not use if seal is broken or missing.

For external use only, not for oral use.

Do not expose to extreme heat.

Questions: (QUESTIONS:)

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070

www.desbio.com

Indications: (INDICATIONS:)

For the temporary relief of strains, sprains, and joint pain.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, Glycerin, L-Arginine Base, Sodium Lactate, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzylalcohol, Dehydroacetic Acid, Glycine, L-Aspartic Acid, Sodium Hyaluronate.

Package Label Display: (PACKAGE LABEL DISPLAY:)

DESBIO

NDC 43742-1333-1

HOMEOPATHIC

TRAUMA

RELIEF GEL

With Aloe Vera

NET WT 4.44 OZ (126 G)

Suggested Application: (SUGGESTED APPLICATION:)

Apply a small amount on the area of discomfort, gently rubbing the gel into the skin. Application should be as soon after the injury as possible. Repeat three times in ten minute intervals; thereafter apply three times daily as needed.

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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