Indications & Usage
Directions: FOR TOPICAL USE ONLY.
Balsamicum Ointment
FDA Label NDC 48951-2159
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 Balsamicum (NDC 48951-2159). 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 Ingredients: Calendula essence 1X, Mercurialis essence (Dog’s mercury) 1X, Resina laricis (Larch resin) 1X, Stibium (Antimony) 1X, Peruvian balsam 1x
Inactive Ingredient
Inactive Ingredients: Organic Olive oil, Lanolin, Sunflower seed oil, Yellow beeswax, Spring water, Organic cane alcohol, Sorbic acid, Tea tree oil, Grapefruit seed extract
Prepared using rhythmical processes.
Otc - Purpose
Uses: Temporary relief of minor wounds.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
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, 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
Uriel, East Troy, WI 53120
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