Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID dc2033a7-a322-4733-8bfe-5a36fe1fa807
Route
TOPICAL
Published
Effective Date 2025-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phytolacca Americana Root (4 [hp_X]) Pseudognaphalium Obtusifolium (3 [hp_X]) Hypericum Perforatum (6 [hp_X]) Citrullus Colocynthis Fruit Pulp (30 [hp_X]) Gelsemium Sempervirens Root Guaiacum Officinale Resin Ledum Palustre Twig Conium Maculatum Flowering Top
Inactive Ingredients
Water Phenoxyethanol Caprylyl Glycol Sorbic Acid Sodium Hydroxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Polyethylene Glycol 1600 Peg-8 Dimethicone Polyethylene Glycol 700 Aloe Vera Leaf .alpha.-tocopherol Edetate Disodium Oregano Potassium Sorbate Arnica Montana Flower Comfrey Leaf Macropiper Methysticum Root Hypericum Perforatum Flower Salix Alba Bark Achillea Millefolium Flower Lavandula Angustifolia Subsp. Angustifolia Flower Ascorbic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-03-17

Description

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

Purpose

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

Purpose:

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

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

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.

Children under 12 years of age: Consult a doctor.

Indications:

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

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

Active Ingredients:

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

Inactive Ingredients:

Water/Arnica (Arnica montana) Flower/Comfrey (Symphytum officinale) Leaf/Kava (Piper methysticum) Root/Poke (Phytolacca americana) Root/St. John's Wort (Hypericum perforatum) Leaf, flower, stem/White Willow (Salix alba) Bark/Yarrow (Achillea millefolium) Flower/Lavender (Lavandula angustifolia) Buds/Ascorbic Acid Extract, Water, Acrylates/C10-30 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, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

Package Label Display:

back, neck and

sciatic rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

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

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.

Children under 12 years of age: Consult a doctor.

Indications: (INDICATIONS:)

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water/Arnica (Arnica montana) Flower/Comfrey (Symphytum officinale) Leaf/Kava (Piper methysticum) Root/Poke (Phytolacca americana) Root/St. John's Wort (Hypericum perforatum) Leaf, flower, stem/White Willow (Salix alba) Bark/Yarrow (Achillea millefolium) Flower/Lavender (Lavandula angustifolia) Buds/Ascorbic Acid Extract, Water, Acrylates/C10-30 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, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

back, neck and

sciatic rescue

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)