Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 03b6e2a9-f335-4ae2-9011-80bd019afb72
Route
TOPICAL
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phytolacca Americana Root (4 [hp_X]) Bellis Perennis (6 [hp_X]) Ledum Palustre Twig (9 [hp_X]) Ruta Graveolens Flowering Top Comfrey Root Magnesium Cation Silicon Dioxide
Inactive Ingredients
Menthol Water Phenoxyethanol Caprylyl Glycol Sorbic Acid Sodium Hydroxide Polyethylene Glycol 1600 Peg-8 Dimethicone Polyethylene Glycol 700 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Tocopherol Aloe Vera Leaf Edetate Disodium Potassium Sorbate Spanish Thyme Oil Ginger Oil Lavender Oil Hypericum Oil Alcohol Citric Acid Monohydrate Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-03-20

Description

(in gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.


Medication Information

Description

(in gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.

Questions

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Warnings:

For external use only. Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not apply to wounds or damaged skin, or mucous membranes. Do not bandage tightly.

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. Do not use if saftey seal is broken or missing.

Directions:

Adults:Apply to affected area not more than 3 to 4 times daily.

Children 2 years of age and older: Consult a health professional. Do not use on children under 2 years of age.

Indications:

May temporarily relieve minor aches and pains of muscles and joints.**

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

Active Ingredients:

(in gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.

Inactive Ingredients:

Purified Water, Aloe Vera Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide (Solution), Tocopherols (Derived from Soy Bean), EDETATE Disodium (EDTA), Ginger (Zingiber Officinale) Root Oil, English Lavender (Lavandula Angustifolia) Flower Oil, Spanish Thyme (Thymus Zygis) Aerial Parts Oil, St. John’s Wort (Hypericum Perforatum) Aerial Parts Oil, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

Package Label Display:

muscle ice

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic

pain relieving 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

Questions (QUESTIONS)

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Warnings: (WARNINGS:)

For external use only. Avoid contact with eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not apply to wounds or damaged skin, or mucous membranes. Do not bandage tightly.

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. Do not use if saftey seal is broken or missing.

Directions: (DIRECTIONS:)

Adults:Apply to affected area not more than 3 to 4 times daily.

Children 2 years of age and older: Consult a health professional. Do not use on children under 2 years of age.

Indications: (INDICATIONS:)

May temporarily relieve minor aches and pains of muscles and joints.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Aloe Vera Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide (Solution), Tocopherols (Derived from Soy Bean), EDETATE Disodium (EDTA), Ginger (Zingiber Officinale) Root Oil, English Lavender (Lavandula Angustifolia) Flower Oil, Spanish Thyme (Thymus Zygis) Aerial Parts Oil, St. John’s Wort (Hypericum Perforatum) Aerial Parts Oil, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

muscle ice

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic

pain relieving 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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