Active Ingredients:
0.17% of Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X
Arnica Plus Gel
FDA Label NDC 43846-0075
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 43846-0075). 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.
Label Section Quick Index
Indications:
May temporarily relieve minor symptoms of sore, overexerted muscles.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May temporarily relieve minor symptoms of sore, overexerted muscles.**
**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 • Conditions 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:
Extract Blend (Arnica (Arnica montana) Leaf, White Willow [Salix alba] Bark, Witch Hazel [Hamamelis virginiana] Bark, Ascorbic Acid, Devil’s Claw [Harpagophytum procumbens] Root, Peppermint [Mentha piperita] Leaf), Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33 (and) Peg-8 Dimethicone (and) Peg-14, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Sodium Hydroxide And 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
paraben-free
formulated in
boulder, co
Net wt. 2 oz. (57 g)
* Please review the disclaimer below.
