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

Tinea-Fix by

Drug Labeling and Warnings

Tinea-Fix by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Vitality Works. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TINEA-FIX 
natrum carbonicum, sulphur, tellurium metallicum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_C]  in 59 mL
TELLURIUM (UNII: NQA0O090ZJ) (TELLURIUM - UNII:NQA0O090ZJ)	TELLURIUM	6 [hp_C]  in 59 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-219-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/14/2019

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works		137752817	manufacture(68703-219) , api manufacture(68703-219)