Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 6fa79c31-e48e-4c83-baa2-96cef22cfee1
Route
TOPICAL
Published
Effective Date 2021-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Croton Tiglium Seed (30 [hp_X]) Chloride Ion Plantago Major Toxicodendron Pubescens Leaf Sarsaparilla
Inactive Ingredients
Water Phytolacca Americana Fruit Aloe Vera Leaf Phenoxyethanol Caprylyl Glycol Sorbic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Polyethylene Glycol 1600 Peg-8 Dimethicone Polyethylene Glycol 700 Larrea Tridentata Leaf Comfrey Leaf Hypericum Perforatum Phytolacca Americana Root Arnica Montana Flower Melissa Officinalis Leaf Salix Alba Bark Achillea Millefolium Flower Sodium Hydroxide Lavandula Angustifolia Subsp. Angustifolia Flower Ascorbic Acid .alpha.-tocopherol Edetate Disodium Oregano Potassium Sorbate Sodium Benzoate Alcohol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-04-16

Description

(in gel): 0.20% of Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla 30X.


Medication Information

Description

(in gel): 0.20% of Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla 30X.

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. • Do not use on broken or abraded skin.

Stop use and ask a doctor if • Rash develops  Condition worsens • Symptoms last more than 7 days. • Do not use if tamper evident seal is broken or missing.

Questions:

888-303-3388

Mon-Fri 8a.m-5p.m CST

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

www.peacefulmountain.com

Directions:

• Apply liberally as needed.

• Children under 12 years of age: Consult a doctor.

Indications:

May temporarily relieve stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

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

Active Ingredients:

(in gel): 0.20% of Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla 30X.

Inactive Ingredients:

Purified Water, Poke (Berries) Phytolacca Americana, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-33, PEG-8 Dimethicone, PEG-14, Chaparral (Leaf) Larrea Tridentata, Comfrey (Leaf) Symphytum Officinale, St. John's Wart (Leaf, Flower, Stem) Hypericum Perforatum, Poke (Root) Phytolacca Americana, Arnica (Flower) Arnica Montana, Lemon Balm (Leaf) Melissa Officinalis, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Sodium Hydroxide, English Lavender (Buds) Lavandula Angustifolia, Ascorbic Acid (Vitamin C), Tocopherols (Vitamin E), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Allergy Alert • Soy

Package Label Display:

peaceful mountain

THE HEIGHT OF HEALTH

derma pain plus+

homeopathic gel

Net wt. 1.4 oz. (40 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. • Do not use on broken or abraded skin.

Stop use and ask a doctor if • Rash develops  Condition worsens • Symptoms last more than 7 days. • Do not use if tamper evident seal is broken or missing.

Questions: (QUESTIONS:)

888-303-3388

Mon-Fri 8a.m-5p.m CST

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

www.peacefulmountain.com

Directions: (DIRECTIONS:)

• Apply liberally as needed.

• Children under 12 years of age: Consult a doctor.

Indications: (INDICATIONS:)

May temporarily relieve stinging pain, skin lesions, itching and burning associated with herpetic eruptions and infection.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in gel): 0.20% of Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Purified Water, Poke (Berries) Phytolacca Americana, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-33, PEG-8 Dimethicone, PEG-14, Chaparral (Leaf) Larrea Tridentata, Comfrey (Leaf) Symphytum Officinale, St. John's Wart (Leaf, Flower, Stem) Hypericum Perforatum, Poke (Root) Phytolacca Americana, Arnica (Flower) Arnica Montana, Lemon Balm (Leaf) Melissa Officinalis, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Sodium Hydroxide, English Lavender (Buds) Lavandula Angustifolia, Ascorbic Acid (Vitamin C), Tocopherols (Vitamin E), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.

Allergy Alert • Soy

Package Label Display: (PACKAGE LABEL DISPLAY:)

peaceful mountain

THE HEIGHT OF HEALTH

derma pain plus+

homeopathic gel

Net wt. 1.4 oz. (40 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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