Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID d5cac1bc-b443-4518-b5b3-8188c2d00926
Route
TOPICAL
Published
Effective Date 2016-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark Toxicodendron Pubescens Leaf
Inactive Ingredients
Water Grape Seed Oil Whey Lecithin, Soybean Sodium Hydroxide Phenoxyethanol Caprylyl Glycol Sorbic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Arnica Montana Flower Aloe Vera Leaf Salix Alba Bark Hamamelis Virginiana Bark Ascorbic Acid Harpagophytum Procumbens Root Polysorbate 20 Tocopherol Mentha Piperita Edetate Disodium Oregano Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2016-05-09 Until 2021-08-22

Description

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.


Medication Information

Description

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.

Warnings:

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

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

When using this product • Do not get into eyes. Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days.

Do not use if safety seal is broken or missing.

Questions:

Dist. By Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Directions:

Apply at least 3 times daily over the affected area.

Indications:

May temporarily relieve minor symptoms of sore, overexerted muscles.**



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

Active Ingredients:

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.

Inactive Ingredients:

Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

Package Label Display:

arnica

plus®

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

formulated in

boulder, co

Net wt. 2 oz. (57g)

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.


Structured Label Content

Warnings: (WARNINGS:)

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

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

When using this product • Do not get into eyes. Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days.

Do not use if safety seal is broken or missing.

Questions: (QUESTIONS:)

Dist. By Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Directions: (DIRECTIONS:)

Apply at least 3 times daily over the affected area.

Indications: (INDICATIONS:)

May temporarily relieve minor symptoms of sore, overexerted muscles.**



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

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

Package Label Display: (PACKAGE LABEL DISPLAY:)

arnica

plus®

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

formulated in

boulder, co

Net wt. 2 oz. (57g)

Keep Out of Reach of Children: (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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