Drug Facts:

Drug Facts:
SPL v6
SPL
SPL Set ID a7fe6ec7-a758-43cf-b46f-c327e0632fb8
Route
TOPICAL
Published
Effective Date 2022-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Borate Ion (30 [hp_X]) Solanum Dulcamara Top Chloride Ion Ranunculus Bulbosus Whole Silicon Dioxide
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Carbomer Homopolymer Type C Larrea Tridentata Leaf Comfrey Leaf Edetate Disodium Lavandula Angustifolia Flower Melissa Officinalis Leaf Oregano Polyethylene Glycol 1600 Peg-8 Dimethicone Polyethylene Glycol 700 Phenoxyethanol Caprylyl Glycol Sorbic Acid Phytolacca Americana Fruit Phytolacca Americana Root Potassium Sorbate Water Sodium Hydroxide St. John's Wort Ascorbic Acid .alpha.-tocopherol Salix Alba Bark Achillea Millefolium Flower Citric Acid Monohydrate Alcohol Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-12-08

Description

(in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.


Medication Information

Description

(in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.

Uses:

May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

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

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

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.

Do not use if tamper evident seal is broken or missing.

Questions:

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

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

www.peacefulmountain.com

Directions:

Apply at least 3 times daily over affected area. Children under 12 years of age: Consult a doctor.

Active Ingredients:



(in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.

Inactive Ingredients:

Water, Chaparral (Larrea Tridentata) Leaf, Comfrey (Symphytum Officinale) Leaf, St. John’s Wort (Hypericum Perforatum) Aerial Parts, Poke (Phytolacca Americana) Root, Arnica (Arnica Montana) Flower, Lemon Balm (Melissa Officinalis) Leaf, White Willow (Salix Alba) Bark, Yarrow (Achillea Millefolium) Flower, English Lavender (Lavandula Angustifolia) Buds, Ascorbic Acid, Poke (Phytolacca Americana) Berries, Aloe Vera 10X Concentrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Alcohol, Citric Acid.

Package Label Display:

homeopathic relief

May temporarily relieve cold sore and fever blisters symptoms

May help temporarily relieve stinging, burning, itching and swelling

peaceful mountain

THE HEIGHT OF HEALTH

formulated in boulder, co

cold sore rescue

homeopathic gel

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

Uses: (USES:)

May temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.**

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

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

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.

Do not use if tamper evident seal is broken or missing.

Questions: (QUESTIONS:)

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

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

www.peacefulmountain.com

Directions: (DIRECTIONS:)

Apply at least 3 times daily over affected area. Children under 12 years of age: Consult a doctor.

Active Ingredients: (ACTIVE INGREDIENTS:)



(in gel): 0.20% of BORAX 30X, DULCAMARA 30X, NATRUM MURIATICUM 30X, RANUNCULUS BULBOSUS 30X, SILICEA 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Chaparral (Larrea Tridentata) Leaf, Comfrey (Symphytum Officinale) Leaf, St. John’s Wort (Hypericum Perforatum) Aerial Parts, Poke (Phytolacca Americana) Root, Arnica (Arnica Montana) Flower, Lemon Balm (Melissa Officinalis) Leaf, White Willow (Salix Alba) Bark, Yarrow (Achillea Millefolium) Flower, English Lavender (Lavandula Angustifolia) Buds, Ascorbic Acid, Poke (Phytolacca Americana) Berries, Aloe Vera 10X Concentrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Edetate Disodium (EDTA), Natural Plant Extract (Origanox WS), Potassium Sorbate, Sodium Benzoate, Alcohol, Citric Acid.

Package Label Display: (PACKAGE LABEL DISPLAY:)

homeopathic relief

May temporarily relieve cold sore and fever blisters symptoms

May help temporarily relieve stinging, burning, itching and swelling

peaceful mountain

THE HEIGHT OF HEALTH

formulated in boulder, co

cold sore rescue

homeopathic gel

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.


Advanced Ingredient Data


Raw Label Data

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