The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Nail Fungus Relief (NDC 68703-217). 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: Hydrofluoricum acidum 6C, Silicea (6C), Thuja occidentalis (6C).
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses+: for symptomatic treatment of common fungal infections of the toenails and fingernails.
+As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
Warnings: Stop use and ask a doctor if symptoms persist or worsen.
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.
May stain clothing.
Directions: Shake before using.
Paint onto affected dry nails 2 times daily and allow to dry.
Continue treatment until a new, healthy nail has appeared.
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: Clove essential oil, hempseed oil, lavender essential oil, tea tree essential 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:
Hydrofluoricum acidum (6C).........................Fibrous tissue
Silicea (6C)...................................................Immune system
Thuja occidentalis (6C).................................Weak nails
* Please review the disclaimer below.
