Tinea-Fix

Manufacturer
Silver Star Brands | Vitality Works
Effective date
2023-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:17

Label at a glance#

ProductTinea-Fix
Active ingredientSULFUR, TELLURIUM, SODIUM CARBONATE
Label structure10 sections

Indications and uses

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.

Dosage and administration

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.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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*

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

OTHER SAFETY INFORMATION

Intended to complement, not replace, standard medical care.

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Apricot kernel oil, clove bud essential oil, lavender essential oil, lemongrass essential oil, tea tree essential oil.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - PURPOSE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinea Fix CartonTinea Fix CartonTinea Fix LabelTinea Fix Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-219-022024-12-04C16284748780-1ba0f9c33-3915-a910-e053-dadaa90a0b85Healthful™ Naturals Tinea-Fix - 59 ml
68703-219-022021-01-29C16284748780-1ba0f9c33-3915-a910-e053-dadaa90a0b85Healthful™ Naturals Tinea-Fix - 59 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-219-02Tinea-Fix59 mL in 1 BOTTLE, SPRAYSPRAY592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-219TINEA-FIX (NATRUM CARBONICUM, SULPHUR, TELLURIUM METALLICUM) SPRAY [SILVER STAR BRANDS]2Legacy NDC, 1 package rows20241206_82e6c71a-205d-1c3e-e053-2991aa0af554.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-21968703-219-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f61eb345-6270-a8cc-e053-2a95a90a7cf782e6c71a-205d-1c3e-e053-2991aa0af5542023-03-04WarningsExact identifier
spl id: f61eb345-6270-a8cc-e053-2a95a90a7cf7
spl set id: 82e6c71a-205d-1c3e-e053-2991aa0af554

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.