Arnica Plus
FDA Label NDC 43846-0060

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peaceful Mountain, Inc. for the product Arnica Plus (NDC 43846-0060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients:

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X.

Indications:

May temporarily relieve minor symptoms of sore, overexerted muscles.**


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

May temporarily relieve minor symptoms of sore, overexerted muscles.**

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

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.

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.

Directions:

Apply at least 3 times daily over the affected area.

Inactive Ingredients:

Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

Questions:

Dist. By Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

Package Label Display:

arnica

plus®

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

formulated in

boulder, co

Net wt. 2 oz. (57g)

* Please review the disclaimer below.