Indications & Usage
Directions: FOR TOPICAL USE ONLY.
Arnica 20%
FDA Label NDC 48951-1374
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 20% (NDC 48951-1374). 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
Apply to skin as needed. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredient: 100 gm contains: 20 gm Arnica 1X
Inactive Ingredient
Inactive Ingredients: Spring water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate, Lavender oil, Sorbic acid, Tea tree oil, Sodium hydroxide, Grapefruit seed extract
Otc - Purpose
Uses: Temporary relief of bruises, sprains and or minor cuts.
prepared using rhythmical processes
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: FOR EXTERNAL USE ONLY
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, if conditions worsen or persist or accidental ingestion occurs. If pregnant or nursing consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.
Otc - Questions
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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