Active Ingredients
Arnica montana 1X
Arnica Active Roll-on
FDA Label NDC 59262-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Arnica Active Roll-on (NDC 59262-102). 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, 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
Purpose
bruises, swelling, aches, sprains, muscle pain, soreness, and stiffness
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• bruising & swelling
• sprains
• backaches
• muscular aches & pains
• strains
• stiffness
Warnings
• FOR EXTERNAL USE ONLY. Do not use on damaged skin, open wounds, or mucous membranes.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Avoid contact with the eyes.
• Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients.
• Do not bandage tightly or use with a heating pad.
• If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For adults and children age 2 and over:
Apply a thin layer to affected area soon as possible after minor injury. Repeat 3 times a day or as needed.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredients
USP water, carbomer, sodium hydroxide, USP ethanol, PEG-8 dimethicone
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration
Principal Display Panel
NDC 59262-102-42
Similasan
Arnica
Active
Roll-On
Pain Relief
74 ml/ 2.5 fl oz
Principal Display Panelndc 59262-102-42similasanarnicaactiveroll-onpain Relief74 mL/ 2.5 Fl Oz (Arnica Active Roll On 01)
* Please review the disclaimer below.
