Active Ingredient
Homeopathic dilution of HPUS Arnica Montana 12c
Arnica 12c Pellet
FDA Label NDC 76472-1127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sevene Usa for the product Arnica 12c (NDC 76472-1127). 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, directions, use, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, other information, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions
(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.
Use
Condition listed above or as directed by a physician.
Warnings
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.
Other Information
Store at room temperature.
Otc - Do Not Use
Do not use if pellet-dispenser seal is broken.
Inactive Ingredient
Sucrose.
Questions?
www.ollois.com * [email protected]* Call 1-855-OLLOMED (Mon-Fri 8am-5pm PST). Made in Canada. Not reviewed by the FDA and not guaranteed to be effective. This Homeopathic dilution may not be suseptible to scientific measurement.
Purpose
Traditionally used for: Pain from trauma - bruises -stiffness - muscle soreness.
Package Label.Principal Display Panel
* Please review the disclaimer below.
