Active Ingredient:
(in gel) Arnica Montana 6X, 12X 0.17%, Hamamelis Virginiana 6X 12X 0.17%, Rhus Tox 6X, 12X 0.17%.
Arnica Plus Gel
FDA Label NDC 70163-0203
9 label sections · Submitted to the FDA by Naturalcare · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Arnica Plus (NDC 70163-0203). 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 ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Arnica Montana – muscle pain, Hamamelis Virginiana – soreness after exertion, Rhus Tox – stiffness after exertion*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.
Uses:
May temporarily relieve minor symptoms of ■ sore, overexerted muscles*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Individual responses may vary, and this product may not work for everyone.
Warnings:
For external use only
When using this product
■ do not get into eyes
Stop use and ask a doctor if
■ pain persists form more than 7 days
■ symptoms do not improve or if they worsen
■ new symptoms occur
■ a rash develops
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.
■ Store at room temperature (65-80°F)
Keep Out Of Reach Of Children:
If swallowed, seek medical help or contact a Poison Control Center immediately.
Directions:
■ Adults and children 12 years and over: apply a thin layer to affected area at least 3 times daily or as needed. Gently massage into the skin until fully absorbed.
■ Children under 12 years of age: consult a doctor.
Inactive Ingredients:
Water/Arnica (Arnica montana) Flower/White Willow (Salix alba) Bark/Witch Hazel (Hamamelis virginiana) Bark/Ascorbic Acid/Devil’s Claw (Harpagophytum procumbens) Root/Peppermint (Mentha piperita) Leaf 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, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid
Questions:
Dist. By NaturalCare
201 Apple Blvd.
Woodbine, IA 51579
www.NaturalCareWorks.com
1-888-280-5672
Package Label Display:
NaturalCare
peaceful mountain
Arnica Plus
Homeopathic Gel
4 oz. (113.4 g)
* Please review the disclaimer below.
