Indications & Usage
Directions: FOR ORAL USE.
Arnica Rosa
FDA Label NDC 48951-1373
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Arnica Rosa (NDC 48951-1373). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredient: Retina et chorioidea (Bovine retina and choroid) 6X, Corpara quadrigemina (Bovine quadrigeminal plate) 7X, Nervus oculomotorius (Bovine third cranial nerve) 8X, Nervus opticus (Bovine second cranial nerve) 8X Arnica 17X, Chrysolith (Silicate of magnesium and iron) 30X
Inactive Ingredient
Inactive Ingredients: Water, Salt, Sodium bicarbonate, Rose oil
prepared using rhythmical processes
Otc - Purpose
Use: Temporary relief of headache.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
KEEP OUT OF REACH OF CHILDREN.
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.
Opened on:_________________
Otc - Questions
Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
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