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

  • 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 28, 2019

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

  • 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

    Nail Fungus Relief Cartonnail Fungus Relief label

  • INGREDIENTS AND APPEARANCE
    NAIL FUNGUS RELIEF 
    hydrofluoricum acidum, silicea, thuja occidentailis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION6 [hp_C]  in 15 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_C]  in 15 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_C]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-217-1515 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(68703-217) , api manufacture(68703-217)