Otc - Active Ingredient
Arnica 6X, HPUS
The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.
Arnica
FDA Label NDC 53645-1000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by True Botanica, Llc for the product Arnica (NDC 53645-1000). 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 otc - active ingredient, otc - purpose, use:, warnings:, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - do not use, directions for use:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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Use:
For help with stress and trauma recovery. May also be used for standard homeopathic indications or as directed by your physician.
Warnings:
Consult your health care provider if symptoms persist more than 5 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Otc - Do Not Use
TAMPER EVIDENT: Do not use if safety seal is broken before first use.
Directions For Use:
Place drops under tongue for 30 seconds. Adults~20 drops 3 times a day. Children 2-12 years ~ 5-10
drops 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.
Other Ingredients:
Citric Acid, Potassium Sorbate, Water.
Otc - Questions
Developed and Made by
True Botanica, LLC
1005 Richards Rd., Suite D
Hartland, WI 53029
800-315-8783
www.truebotanica.com
Principal Display Panel
Display Panel (Arnica 6x Otc 01)
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