Inactive Ingredient
Inactive Ingredient: Alcohol base to preserve product.
Bestmade Natural Products Berberis Vulgaris Tincture
FDA Label NDC 82969-5121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bestmade Natural Products for the product Bestmade Natural Products Berberis Vulgaris (NDC 82969-5121). 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 inactive ingredient, indications & usage, otc - purpose, dosage & administration, otc - active ingredient, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Use: Temporarily relieves discomfort and pain in the kidney area and colic-like discomfort; scalp tightness, urinary irritation, itching, skin pigmentation, and nausea before breakfast.*
Otc - Purpose
Use: Temporarily relieves discomfort and pain in the kidney area and colic-like discomfort; scalp tightness, urinary irritation, itching, skin pigmentation, and nausea before breakfast.*
Dosage & Administration
Dosage Instructions: 10 drops in a spoon of water 3 times a day. For people under 100lb: use half a dose or take as prescribed.
Otc - Active Ingredient
Active Ingredient: Berberis Vulgaris Ø (HPUS)
Otc - Keep Out Of Reach Of Children
Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Warnings
Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Package Label.Principal Display Panel
Entire Package Label
* Please review the disclaimer below.
