Label: H-NAIL FUNGUS FORMULA- calendula officinalis, silicea, thuja occidentalis oil

  • NDC Code(s): 61077-123-11, 61077-123-33
  • Packager: Healing Natural Oils LLC
  • 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 December 27, 2017

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  • Active Ingredients:

    Calendula officinalis - 12C HPUS
    Silicea -12C HPUS  
    Thuja occidentalis - 12C HPUS  

  • Purpose

    Calendula officinalis - 12C HPUS (healing agent)
    Silicea -12C HPUS   (crippled nails)
    Thuja occidentalis - 12C HPUS  (for fungus)

    The letters ‘HPUS’ indicate that the components in this product are officially
    monographed in the Homoeopathic Pharmacopoeia of the United States
  • Inactive Ingredients:


    Corylus avellana nut oil, Essential Oil Blend (Cymbopogon flexuosus whole plant, Cymbopogon martinii
    aerial parts, Lavandula officinalis flower bud, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant,
    Thymus vulgaris stems and leaves)

  • Indications:

    For the temporary relief of nail fungus symptoms, such as fungus growth, disfigured or crippled nails.

  • Directions:

    Adults and Children 4 yrs and over:  Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
    Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.
    Perform skin test prior to initial use.

    Do not use if pregnant or breastfeeding.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control
    Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    H-Nail Fungus
    Formula

    Homeopathic

    For External Use Only

    123

    11ml (0.37 fl. oz)
    amoils.com

    Nail Fungus Label

  • INGREDIENTS AND APPEARANCE
    H-NAIL FUNGUS FORMULA  
    calendula officinalis, silicea, thuja occidentalis oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP12 [hp_C]  in 11 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_C]  in 11 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    CYMBOPOGON FLEXUOSUS WHOLE (UNII: 0MK18YOA5G)  
    CYMBOPOGON MARTINI TOP (UNII: 7K1N3UZ6DU)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-123-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-123-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(61077-123)
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