Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 2c2f24ad-f4bd-468b-9c84-290dcbf2ba1a
Route
TOPICAL
Published
Effective Date 2016-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (30 [hp_X]) Fagopyrum Esculentum Goldenseal Centella Asiatica Juglans Regia Leaf Juglans Regia Fruit Rind, Immature Vinca Minor
Inactive Ingredients
Water Phytolacca Americana Fruit Olive Oil Avocado Oil Macadamia Oil Phenoxyethanol Caprylyl Glycol Sorbic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Polyethylene Glycol 1500 Peg-8 Dimethicone Polyethylene Glycol 700 Kukui Nut Oil Polysorbate 20 Larrea Tridentata Leaf Phytolacca Americana Root Sodium Hydroxide Arnica Montana Flower St. John's Wort Salix Alba Bark Sanguinaria Canadensis Root Comfrey Leaf Ascorbic Acid Azadirachta Indica Leaf Calendula Officinalis Flower .alpha.-tocopherol Edetate Disodium Origanum Vulgare Subsp. Hirtum Flower Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2012-09-14 Until 2025-10-20

Description

Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X


Medication Information

Description

Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

Section 53413-1

Dist by:

Peaceful Mountain, Inc.

Woodbine, IA 51579    883-303-3388

www.peacefulmountain.com

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.

ALLERGY ALERT:  Macadamia and Kukui Nut Oils, Soy

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 eczema.**

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

Active Ingredients:

Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

Inactive Ingredients:

Purified Water, Poke (Berry) Phytolacca Americana, Olive Oil (Olea Europaea), Avocado Oil (Persea Gratissima), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33, PEG 8 DIMETHICONE, PEG-14, Kukui Nut Oil (Aleurites Moluccana), Polysorbate 20, Chaparral Leaf (Larrea Tridentata), Poke Root (Phytolacca Americana), Arnica Montana Flower, St. Johns Wort Aerial Parts (Hypericum Perforatum), White Willow Bark (Salix Alba), Bloodroot Root (Sanguinaria Canadensis), Comfrey Leaf (Symphytum Officinale), Ascorbic Acid, Neem Leaf (Azadirachta Indica), Calendula Officinalis Flower, Vitamin E Oil, Edetate Disodium (EDTA), Oregano, Potassium Sorbate

Package Label Display:

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

homeopathic lotion

formulated in boulder, co

Net wt. 0.25 oz, (7 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

Section 53413-1 (53413-1)

Dist by:

Peaceful Mountain, Inc.

Woodbine, IA 51579    883-303-3388

www.peacefulmountain.com

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.

ALLERGY ALERT:  Macadamia and Kukui Nut Oils, Soy

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 eczema.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Poke (Berry) Phytolacca Americana, Olive Oil (Olea Europaea), Avocado Oil (Persea Gratissima), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33, PEG 8 DIMETHICONE, PEG-14, Kukui Nut Oil (Aleurites Moluccana), Polysorbate 20, Chaparral Leaf (Larrea Tridentata), Poke Root (Phytolacca Americana), Arnica Montana Flower, St. Johns Wort Aerial Parts (Hypericum Perforatum), White Willow Bark (Salix Alba), Bloodroot Root (Sanguinaria Canadensis), Comfrey Leaf (Symphytum Officinale), Ascorbic Acid, Neem Leaf (Azadirachta Indica), Calendula Officinalis Flower, Vitamin E Oil, Edetate Disodium (EDTA), Oregano, Potassium Sorbate

Package Label Display: (PACKAGE LABEL DISPLAY:)

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

homeopathic lotion

formulated in boulder, co

Net wt. 0.25 oz, (7 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.


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