The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Gout Calm (NDC 68703-218). 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 hpus* active ingredients, uses+:, warnings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C).
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses+: For symptomatic treatment of gout joint pain and inflammation.
+ As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
Warnings: If symptoms persist or worsen, discontinue use immediately and consult a healthcare professional.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
For external use only.
Avoid using near eyes or mouth.
If swallowed, get medical help or contact a Poison Control Center immediately.
Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.
Directions: Shake well before using.
Spray onto entire affected area and massage into skin every 2 hours until pain begins to subside.
Adults and children over 12 years of age.
Other information:
Intended to complement, not replace, standard medical care.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive ingredients: Basil essential oil, black pepper essential oil, celery essential oil, grapeseed oil.
Keep out of reach of children.
If pregnant or breast-feeding, ask a health care professional before use.
HPUS* Active ingredients Purpose+
Equal volumes of each ingredient as follows:
Antimonium crudum (6C)..................................Stiffness, swelling
Berberis vulgaris (30C).....................................Burning pain
Lithium carbonicum (6C)..................................Joint pain
* Please review the disclaimer below.
