Indications & Usage
Directions: FOR ORAL USE ONLY.
Amethyst Rosa
FDA Label NDC 48951-1361
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 Amethyst Rosa (NDC 48951-1361). 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: 1-2 capsules. Ages 2-11: 1 capsule. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: Amethyst (Nat. silicic acid anhydrate with traces of manganese and iron) 2X, Antimonite (Nat. antimony trisulfide)5x, Carbo betulae (Birch wood charcoal) 2X, Fumaria (Fumitory) 3X, Graphite (Foliated crystalline carbon) 15X.
Inactive Ingredient
Inactive Ingredients: Vegetable capsules, Diatomaceous earth, Distilled water, Rose petal extract, Anise oil, Caraway oil
Hematite (Red iron ore), Absinthium (Wormwood), Betula (Borage), Calamus (Sweet flag), Chamomilla (Chamomile), Cochlearia (Common scurvy grass), Gentiana (Yellow gentian), Geum urbanum (Herb bennet), Oxalis (Wood sorrel), Rosa (Garden rose), Urtica dioica (Stinging nettle), Urtica dioica (Stinging nettle), Zingiberis (Ginger), Piper nigrum (Black pepper).
Otc - Purpose
Use: Temporary relief of acne.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Allergen Statement: This product was produced on equipment that also processes products that contain lactose.
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.
Otc - Questions
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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