TINEA-FIX- natrum carbonicum, sulphur, tellurium metallicum spray 
Silver Star Brands

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.

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Healthful™ Naturals Tinea-Fix - 59 ml

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.

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.

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

Tinea Fix CartonTinea Fix Label

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)

Revised: 2/2019
Document Id: 82e6c71a-205e-1c3e-e053-2991aa0af554
Set id: 82e6c71a-205d-1c3e-e053-2991aa0af554
Version: 1
Effective Time: 20190227
 
Silver Star Brands