Label: ACNE CARE- calendula officinalis flowering top, geranium maculatum root, and silicon dioxide solution/ drops

  • NDC Code(s): 51393-6111-1, 51393-6111-2
  • 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 August 24, 2010

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Indications

    Clears up acne blemishes; for the relief of skin inflammation, soreness and redness associated with acne.

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  • 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*
    Equal parts of: Purpose
    Calendula Officinalis 6X promotes healthy skin
    Geranium maculatum 6X helps unhealthy skin, skin ulcers, helps clear acne
    Silicea 6X helps acne, face eruptions
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  • Inactive Ingredients

    Pelargonium Graveolens Leaf Oil, Lavandin Oil, Palmarosa Oil, Rosemary Oil, Tea Tree Oil

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  • Directions

    Wash face thoroughly with soap and warm water. Moisten cotton ball with warm water. Allow 2-3 drops of product to fall onto moistened cotton ball. Gently rub moistened cotton ball over all areas of acne. Can also be applied directly from the bottle. Repeat process three times per day.

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  • Warnings

    Some individuals may be sensitive to essential 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.

    As with any drug if you are pregnant or breast feeding, seek the advice of a health care professional before using this product.

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

    Keep all medicines out of the reach of children. In case of accidental ingestion more of than several drops of product, or if any adverse reaction occurs, get medical help or contact a Poison Control Center.

    Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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  • 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

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  • SPL UNCLASSIFIED SECTION

    NDC#: 51393-1233-1 (11ml) // 51393-1233-2 (33ml)

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  • Principal Display Panel - 11 ml Bottle Label

    Forces of Nature

    Acne Care

    0.38 fl. oz. / 11 ml

    Principal Display Panel - 11 ml Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ACNE CARE 
    calendula officinalis flowering top, geranium maculatum root, and silicon dioxide solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51393-6111
    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 6 [hp_X]  in 1000 mL
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ) GERANIUM MACULATUM ROOT 6 [hp_X]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 6 [hp_X]  in 1000 mL
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51393-6111-1 11 mL in 1 BOTTLE, DISPENSING
    2 NDC:51393-6111-2 33 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 09/01/2010
    Labeler - Forces of Nature (050169130)
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