Otc - Active Ingredient
Active Ingredient: Arnica Montana 12 C
Arnica Pellet
FDA Label NDC 0220-0508
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Arnica (NDC 0220-0508). 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 otc - active ingredient, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Use for trauma, bruises, muscle soreness, or as directed by a physician.
Warnings
Warnings:
• Do not use if pellet-dispenser seal is broken.
Otc - Stop Use
• Stop use and ask a physician if symptoms persist for more than 3 days or worsen.
Otc - Pregnancy Or Breast Feeding
• If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children.
Dosage & Administration
Directions (Adults/Children):
Dissolve 5 pellets in the mouth 3 times a day until symptoms are relieved or as
directed by a physician.
How Supplied
Other Information:
• Contains approx. 80 pellets
• Made according to the HPUS
Inactive Ingredient
Inactive Ingredients: Sucrose, Lactose
Otc - Questions
Questions, Comments?
www.boironusa.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Newtown Square, PA 19073-3267
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