Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 0b20a36b-0ddc-4694-a391-ca6bcfa561a8
Route
TOPICAL
Published
Effective Date 2018-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (3 [hp_X]) Ruta Graveolens Flowering Top (6 [hp_X]) Bellis Perennis (12 [hp_X]) Capsicum (30 [hp_X]) Ledum Palustre Twig Comfrey Root Whey Colchicum Autumnale Bulb Rhododendron Aureum Leaf
Inactive Ingredients
Water Phenoxyethanol Caprylyl Glycol Sorbic Acid Sodium Hydroxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Polyethylene Glycol 1500 Peg-8 Dimethicone Polyethylene Glycol 700 Aloe Vera Leaf Tocopherol Edetate Disodium Oregano Potassium Sorbate Arnica Montana Flower Comfrey Leaf Salix Alba Bark Celery Seed Harpagophytum Procumbens Root Feverfew Phytolacca Americana Root Ascorbic Acid Turmeric

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-12-12

Description

(in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X


Medication Information

Description

(in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X

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 joint pain and inflammation and tendon and soft tissue discomfort.**

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

Active Ingredients:

(in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X

Inactive Ingredients:

Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Sodium Hydroxide (Solution), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Tocopherols [Vitamin E Oil] (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Arnica (flower), Comfrey (leaf), White Willow (bark), Celery (seed), Devil’s Claw (root), Feverfew (leaf), Poke (root), Ascorbic Acid, Turmeric (Root).

Package Label Display:

joint and tendon rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in

boulder, co

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.

Children under 12 years of age: Consult a doctor.

Indications: (INDICATIONS:)

May temporarily relieve minor symptoms of joint pain and inflammation and tendon and soft tissue discomfort.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Sodium Hydroxide (Solution), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Tocopherols [Vitamin E Oil] (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Arnica (flower), Comfrey (leaf), White Willow (bark), Celery (seed), Devil’s Claw (root), Feverfew (leaf), Poke (root), Ascorbic Acid, Turmeric (Root).

Package Label Display: (PACKAGE LABEL DISPLAY:)

joint and tendon rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in

boulder, co

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


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