Label: ACNE CARE- calendula officinalis flowering top, geranium maculatum root, 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Indications

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

  • 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 6Xpromotes healthy skin
    Geranium maculatum 6Xhelps unhealthy skin, skin ulcers, helps clear acne
    Silicea 6Xhelps acne, face eruptions
  • Inactive Ingredients

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

  • 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.

  • 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.

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

  • 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
  • INGREDIENTS AND APPEARANCE
    ACNE CARE 
    calendula officinalis flowering top, geranium maculatum root, and silicon dioxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-6111
    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 TOP6 [hp_X]  in 1000 mL
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ) GERANIUM MACULATUM ROOT6 [hp_X]  in 1000 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide6 [hp_X]  in 1000 mL
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-6111-111 mL in 1 BOTTLE, DISPENSING
    2NDC:51393-6111-233 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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