Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID c50ff4ba-70d4-43f7-afef-13fc296fc9c1
Route
TOPICAL
Published
Effective Date 2021-06-25
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 Hypericum Perforatum Salix Alba Bark Sanguinaria Canadensis Root Comfrey Leaf Ascorbic Acid Azadirachta Indica Leaf Calendula Officinalis Flower .alpha.-tocopherol Edetate Disodium Oregano Potassium Sorbate Sodium Benzoate Citric Acid Monohydrate Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-03-19

Description

(in lotion): 0.15% of Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X.


Medication Information

Description

(in lotion): 0.15% of Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X.

Warnings:

For external use only

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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away. 

If pregnant or breast-feeding, ask a health professional before use.

Questions:

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579    

888-303-3388 Mon thru Fri 8 a.m. - 5 p.m. CT

www.peacefulmountain.com

Directions:

Apply at least 3 times daily over affected area. For external use only.  

Children under 12 years of age: Consult a doctor.

Indications:

May temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning •Itching •Dry •Rough •Scaly •Chapped •Cracked skin •Rashes •Urticaria (hives) •Eruptions •Generally unhealthy skin.**

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

Active Ingredients:

(in lotion): 0.15% of 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 Americana), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30alkyl 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, Sodium Hydroxide (Solution), Arnica (Flower) Arnica Montana, St. John’s Wort (Aerial Parts) Hypericum Perforatum, White Willow (Bark) Salix Alba, Bloodroot (Root) Sanguinaria Canadensis, Comfrey (Leaf) Symphytum Officinale, Ascorbic Acid (Vitamin C Powder), Neem (Leaf) Azadirachta Indica, Calendula (Flower) Calendula Officinalis, Tocopherols (Vitamin E Oil) From Soy, Edetate Disodium (EDTA), Oregano, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display:

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

soothing rash relief

homeopathic

lotion

Net wt. 1 oz. (28 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

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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away. 

If pregnant or breast-feeding, ask a health professional before use.

Questions: (QUESTIONS:)

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579    

888-303-3388 Mon thru Fri 8 a.m. - 5 p.m. CT

www.peacefulmountain.com

Directions: (DIRECTIONS:)

Apply at least 3 times daily over affected area. For external use only.  

Children under 12 years of age: Consult a doctor.

Indications: (INDICATIONS:)

May temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning •Itching •Dry •Rough •Scaly •Chapped •Cracked skin •Rashes •Urticaria (hives) •Eruptions •Generally unhealthy skin.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in lotion): 0.15% of 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 Americana), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30alkyl 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, Sodium Hydroxide (Solution), Arnica (Flower) Arnica Montana, St. John’s Wort (Aerial Parts) Hypericum Perforatum, White Willow (Bark) Salix Alba, Bloodroot (Root) Sanguinaria Canadensis, Comfrey (Leaf) Symphytum Officinale, Ascorbic Acid (Vitamin C Powder), Neem (Leaf) Azadirachta Indica, Calendula (Flower) Calendula Officinalis, Tocopherols (Vitamin E Oil) From Soy, Edetate Disodium (EDTA), Oregano, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

soothing rash relief

homeopathic

lotion

Net wt. 1 oz. (28 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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