Indications & Usage
Directions: FOR TOPICAL USE ONLY.
Calendula 10%
FDA Label NDC 48951-4165
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 Calendula 10% (NDC 48951-4165). 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: 50 gm Calendula 1X
Inactive Ingredient
Inactive Ingredients: Distilled water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate,
Lavender oil, Sodium hydroxide, Sorbic acid, Tea tree oil, Grapefruit seed extract
Otc - Purpose
Uses: Temporary relief of minor cuts and wounds.
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
www.urielpharmacy.com Lot#
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