Indications & Usage
Directions: FOR ORAL USE ONLY.
Arnica Calendula Special Order
FDA Label NDC 48951-1248
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 Calendula Special Order (NDC 48951-1248). 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: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredient: 100gm contains: 2.5gm Arnica e flor. 1X, 1.65gm Calendula ex herba 1X, 1.65 Echinacea ex herba 1X, 0.1gm Quartz 1X, 0.1gm Stibium 1X
Inactive Ingredient
Inactive Ingredient: Diatomaceous earth
Otc - Purpose
Use: Temporary relief of minor bruises, cuts and scrapes.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: 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 Uriel, East Troy, WI 53120 www.urielpharmacy.com
Package Label.Principal Display Panel
Product Label (Arncalpowso)
* Please review the disclaimer below.
