Arnica Gel 15 Gel
FDA Label NDC 80004-400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitamedica, Inc. for the product Arnica Gel 15 (NDC 80004-400). 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:, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Arnica Montana 200C HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. This product has been manufactured at an FDA-regulated facility.

Purpose:

Arnica Montana - Disoloration from bruising; relieves join and muscle pain, soreness & stiffness; relieves swelling from *

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

Uses:

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiff • Muscle Soreness 

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

Warnings:

For extrenal use only. Avoid contract with eyes and mucous membranes.

Do not use on open wounds or broken skin

Stop use or consult a physician if

• A rash or irritation occurs

• Symptoms persist for more than 7 days or worsen.

Keep this and all medications out of reach of children.

If sawllowed, seek medical attention or contact a Poison control center immediately.

Keep Out Of Reach Of Children:

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions:

Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

Inactive Ingredients:

Water, Aloe Vera Leaf Juice Extract, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol

Questions:

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33624

©2024 VitaMedica, Inc.

www.vitamedica.com

888-367-8605

[email protected]

* Please review the disclaimer below.