The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Tinea-fix (NDC 68703-219). 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: Natrum cardonicum (30C), Sulphur (6C), Tellurium metallicum (6C).
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses+: For symptomatic treatment of Tinea Versicolor: fungal imbalance, skin discoloration, and itching & scaling of the skin.
+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 persit 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 twice daily.
Allow the spray to dry completely before putting on clothes.
Adults and children over 12 years of age.
Intended to complement, not replace, standard medical care.
Tamper resistant for your protection. Use only if safety seal is intact.
Inactive ingredients: Apricot kernel oil, clove bud essential oil, lavender essential oil, lemongrass essential oil, tea tree essential oil.
Keep out of reach of children.
If pregnant or breast-feeding, ask a healthcare professional before use.
HPUS* Active ingredients Purpose+
Equal volumes of each ingredient as follows:
Natrum carbonicum (30C)................................Scaling skin
Sulphur (6C).....................................................Itching
Tellurium metallicum (6C)................................Itchy, patchy skin
* Please review the disclaimer below.
