Label: NAIL FUNGUS CONTROL EXTRA STRENGTH- calendula officinalis flowering top, silicon dioxide, and hypericum perforatum solution/ drops

  • NDC Code(s): 51393-6989-1, 51393-6989-2
  • Packager:  Forces of Nature
  • 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 November 5, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients*
    Equal parts of:
    Purpose
    *
    The letters 'HPUS' indicate that the component(s) in this product is (are) officially monographed in the Homœopathic Pharmacopœia of the United States.
    Calendula Officinalis 8X HPUS Promotes healthy skin and healing
    Hypericum perfoliatum 8X HPUS Remedy for difficulties with nails
    Silicea 8X HPUS Remedy for nail ulcers, fowl smelling, crippled nails
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  • Also Includes

    Certified Organic oils of: East Indian Lemongrass, Pelargonium Graveolens Leaf, Sesame Seed, Tea Tree, French Thyme, South East Asian Clove

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  • Directions

    Wash and thoroughly dry the affected area. Apply 1-2 drops and gently rub into affected area 3 times per day. Wash hands afterwards.

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  • Indications

    For the relief and treatment of pain, soreness and inflammation from nail fungus.

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  • Warnings

    If skin symptoms worsen, redness, bleeding or pus occurs consult a health care professional.

    Keep out of the reach of children. If accidental ingestion of several drops, get medical help or contact a Poison Control Center.

    For external use only, do not apply to the eyes or mucous membranes.

    Keep all medicines out of the reach of children.

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  • PRINCIPAL DISPLAY PANEL - 11ml Bottle Label

    FORCES OF NATURE ®

    Nail Fungus
    CONTROL
    EXTRA STRENGTH

    HOMEOPATHIC
    MEDICINE
    FDA REGISTERED
    +
    USDA
    ORGANIC

    11ml

    PRINCIPAL DISPLAY PANEL - 11ml Bottle Label
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  • INGREDIENTS AND APPEARANCE
    NAIL FUNGUS CONTROL   EXTRA STRENGTH
    calendula officinalis flowering top, silicon dioxide, and hypericum perforatum solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-6989
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top 8 [hp_X]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 8 [hp_X]  in 1000 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 8 [hp_X]  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    Tea Tree Oil (UNII: VIF565UC2G)  
    Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG)  
    Clove Oil (UNII: 578389D6D0)  
    East Indian Lemongrass Oil (UNII: UP0M8M3VZW)  
    Thyme Oil (UNII: 2UK410MY6B)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51393-6989-1 11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011
    2 NDC:51393-6989-2 33 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/06/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 04/06/2011
    Labeler -  Forces of Nature (050169130)
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