Label: TINEA-FIX- natrum carbonicum, sulphur, tellurium metallicum spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 27, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • HPUS Active Ingredients

    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*

    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: 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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

    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

  • PRINCIPAL DISPLAY PANEL

    Tinea Fix CartonTinea Fix Label

  • INGREDIENTS AND APPEARANCE
    TINEA-FIX 
    natrum carbonicum, sulphur, tellurium metallicum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_C]  in 59 mL
    TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ) TELLURIUM6 [hp_C]  in 59 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE30 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    CLOVE OIL (UNII: 578389D6D0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-219-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/14/2019
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works137752817manufacture(68703-219) , api manufacture(68703-219)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!