drug facts:

drug facts:
SPL v1
SPL
SPL Set ID 69e74c40-7633-4935-a66a-e471324b6640
Route
topical
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (3 [hp_X]) toxicodendron pubescens leaf (4 [hp_X]) phytolacca americana root (12 [hp_X]) anemone pulsatilla ruta graveolens flowering top
Inactive Ingredients
water phenoxyethanol caprylyl glycol sorbic acid sodium hydroxide carbomer copolymer type a (allyl pentaerythritol crosslinked) polyethylene glycol 1600 peg-8 dimethicone (600 cst) polyethylene glycol 700 aloe vera leaf .alpha.-tocopherol edetate disodium oregano potassium sorbate arnica montana flower comfrey leaf salix alba bark hamamelis virginiana bark ascorbic acid sodium benzoate alcohol citric acid monohydrate

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2024-06-11

Purpose

May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

0.20% of Arnica Montana 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Rhus Tox 4X, Ruta Graveolens 12X.


Medication Information

Purpose

May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

0.20% of Arnica Montana 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Rhus Tox 4X, Ruta Graveolens 12X.

Purpose:

May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.**

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

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

Questions:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

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 muscle aches, pains from overexertion, and injury.**

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

Active Ingredients:

0.20% of Arnica Montana 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Rhus Tox 4X, Ruta Graveolens 12X.

Inactive Ingredients:

Water/Arnica (Arnica Montana) Flower/Comfrey (Symphytum officinale) Leaf/White Willow (Salix Alba) Bark/Witch Hazel (Hamamelis Virginiana) Bark/Ascorbic Acid Extract, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid

Package Display Label:

Muscle rescue

Peaceful Mountain

homeopathic gel

Net wt. 2 oz. (57 g)

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

May temporarily relieve minor symptoms of muscle aches, pains from overexertion, and injury.**

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

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

Questions: (QUESTIONS:)

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

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 muscle aches, pains from overexertion, and injury.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

0.20% of Arnica Montana 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Rhus Tox 4X, Ruta Graveolens 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water/Arnica (Arnica Montana) Flower/Comfrey (Symphytum officinale) Leaf/White Willow (Salix Alba) Bark/Witch Hazel (Hamamelis Virginiana) Bark/Ascorbic Acid Extract, Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherols (Soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid

Package Display Label: (PACKAGE DISPLAY LABEL:)

Muscle rescue

Peaceful Mountain

homeopathic gel

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.


Advanced Ingredient Data


Raw Label Data

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