Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 613ddf6c-ba89-4b98-8576-d2cd38f6910a
Route
TOPICAL
Published
Effective Date 2023-08-07
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 Phenoxyethanol Caprylyl Glycol Sorbic Acid Sodium Hydroxide Polyethylene Glycol 1600 Peg-8 Dimethicone Polyethylene Glycol 700 Aloe Vera Leaf .alpha.-tocopherol Edetate Disodium Oregano Potassium Sorbate Arnica Montana Flower Salix Alba Bark Hamamelis Virginiana Bark Ascorbic Acid Harpagophytum Procumbens Root Mentha Piperita Leaf Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Alcohol Sodium Benzoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-14

Description

0.17% of Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X


Medication Information

Description

0.17% of 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 • Conditions 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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

0.17% of Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X

Inactive Ingredients:

Water, Arnica (Arnica Montana) Flower, White Willow (Salix Alba) Bark, Witch Hazel (Hamamelis Virginiana) Bark, Ascorbic Acid, Devil’s Claw (Harpagophytum Procumbens) Root, Peppermint (Mentha Piperita) Leaf, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Peg-33, Peg-8 Dimethicone, Peg-14, Sodium Hydroxide, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display:

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

Net wt. 2 oz. (57 g)

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 • Conditions 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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

0.17% of Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Arnica (Arnica Montana) Flower, White Willow (Salix Alba) Bark, Witch Hazel (Hamamelis Virginiana) Bark, Ascorbic Acid, Devil’s Claw (Harpagophytum Procumbens) Root, Peppermint (Mentha Piperita) Leaf, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Peg-33, Peg-8 Dimethicone, Peg-14, Sodium Hydroxide, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

Net wt. 2 oz. (57 g)

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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