NAIL FUNGUS RELIEF- hydrofluoricum acidum, silicea, thuja occidentailis liquid

Nail Fungus Relief by

Drug Labeling and Warnings

Nail Fungus Relief 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: Hydrofluoricum acidum 6C, Silicea (6C), Thuja occidentalis (6C).

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

Uses+: for symptomatic treatment of common fungal infections of the toenails and fingernails.

+As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

Warnings: Stop use and ask a doctor if symptoms persist or worsen.

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.

May stain clothing.

Directions

Directions: Shake before using.

Paint onto affected dry nails 2 times daily and allow to dry.

Continue treatment until a new, healthy nail has appeared.

Adults and children over 12 years of age.

OTHER SAFETY INFORMATION

Other 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: Clove essential oil, hempseed oil, lavender 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 health care professional before use.

PURPOSE

HPUS* active ingredients Purpose+

Equal volumes of each ingredient as follows:

Hydrofluoricum acidum (6C).........................Fibrous tissue

Silicea (6C)...................................................Immune system

Thuja occidentalis (6C).................................Weak nails

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAIL FUNGUS RELIEF 
hydrofluoricum acidum, silicea, thuja occidentailis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	6 [hp_C]  in 15 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 [hp_C]  in 15 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	6 [hp_C]  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-217-15	15 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(68703-217) , api manufacture(68703-217)