Active Ingredient
Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X
Homeopathic Arnica Drops Lozenge
FDA Label NDC 57556-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Historical Remedies Llp for the product Homeopathic Arnica Drops (NDC 57556-001). 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 active ingredient, indications, warning, directions, inactive ingredients:, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications
For temporary relief of aching, strained muscles, bumps and bruises. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Warning
If symptoms persist more than 7 days or worsen, consult a physician.
Keep out of children’s reach. In case of overdose, get medical help or contact a poison control center right away.
If pregnant or breast-feeding, ask a doctor before use.
Do not use if shrink wrap is broken or missing.
Directions
Adults & children over 8: dissolve one lozenge in mouth. Repeat every half hour as needed.
Inactive Ingredients:
Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, tangerine flavor.
4 calories per lozenge. 1 gram sugar per lozenge.
No gluten added. Vegan.
Product Label
Label (Label)
* Please review the disclaimer below.
