Label: NAIL FUNGUS CONTROL- calendula officinalis flowering top, geranium maculatum root, hypericum perforatum, and silicon dioxide solution/ drops

  • 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 August 24, 2010

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  • Indications

    For the temporary relief of pain, soreness and inflammation around nails.

  • ACTIVE INGREDIENT

    *
    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homœopathic Pharmacopœia of the United States.
    Homeopathic Active Ingredients*
    For bottle:
    Calendula Officinalis 8X HPUSPromotes healthy skin and healing
    Geranium Maculatum 8X HPUSHeals ulcers in skin
    Hypericum perfoliatum 8X HPUSRemedy for difficulties with nails
    Silicea 8X HPUSRemedy for nail ulcers, fowl smelling, crippled nails
  • Inactive Ingredients

    East Indian Lemongrass Oil, Pelargonium Graveolens Leaf Oil, Sesame Seed Oil, Tea Tree Oil, South East Asian Clove Oil

  • Directions

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

  • Warnings

    If symptoms worsen, or redness or skin irritation occurs, discontinue product. Some individuals may be sensitive to tea tree or other oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.

    If you are pregnant or breast-feeding, ask a health professional before use.

    Keep out of the reach of children. If accidental ingestion, 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.

    Product Note: Nail Fungus infections may begin as a white or yellow spot under the tip of your fingernail or toenail. As the nail fungus spreads deeper into your nail, it may cause your nail to discolor, thicken and develop crumbling edges. If condition worsens consult a physician.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Forces of Nature, Inc.
    55 Galli Drive, Suite C
    Novato, CA 94949 USA
    www.fonworld.org

  • Product questions?

    877-975-3797

  • SPL UNCLASSIFIED SECTION

    NDC#: 51393-6889-1 (11ml) // 51393-6889-2 (33ml)

  • PRINCIPAL DISPLAY PANEL - 11 ml Bottle Label

    Forces of Nature

    Nail Fungus Control
    EXTRA-STRENGTH

    0.38 fl. oz. / 11 ml

    PRINCIPAL DISPLAY PANEL - 11 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    NAIL FUNGUS CONTROL   EXTRA STRENGTH
    calendula officinalis flowering top, geranium maculatum root, hypericum perforatum, and silicon dioxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-6889
    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 TOP8 [hp_X]  in 1000 mL
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ) GERANIUM MACULATUM ROOT8 [hp_X]  in 1000 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 1000 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1000 mL
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-6889-111 mL in 1 BOTTLE, DISPENSING
    2NDC:51393-6889-233 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC09/01/2010
    Labeler - Forces of Nature (050169130)
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