Indications & Usage
Directions: FOR Topical USE ONLY.
Calendula 5% Special Order
FDA Label NDC 48951-3215
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 5% Special Order (NDC 48951-3215). 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
Use or as needed. Ages 12 and older: 2-3 sprays. Ages 2-11: 1-2 sprays. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: 100gm spray contain: 5gm Calendula 1X
Inactive Ingredient
Inactive Ingredients: Distilled water, Sodium chloride, Tea tree oil, Grapefruit seed extract
Otc - Purpose
Use: Temporary relief of headache.
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 or if conditions worsen or
persist. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seals on box are broken or missing.
SHAKE WELL BEFORE USE
Otc - Questions
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.urielpharmacy.com
Package Label.Principal Display Panel
Calendula5sospray (Calendula5sospray)
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