Label: SHINGLES CONTROL- calendula officinalis flowering top, hypericum perforatum, and sodium chloride 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 March 31, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 HPUSPromotes healthy skin
    Natrum Muriaticum 8X HPUS Remedy for herpes, skin eruptions, hives
    Hypericum Perforatum 8X HPUSFor herpes zoster/shingles
  • Also Includes

    Certified Organic Oils of: Eucalypus Radiata Leaf, French Lavandin Super, Napalese Palmarosa, Tea Tree, Pelargonium Graveolens Leaf, Cypress

  • Directions

    Apply to affected area at first sign of an outbreak 3-5 times per day. Avoid contact with eyes.

  • Indications

    For relief and treatment of skin inflammation, pain and redness of shingles outbreaks.

  • Warnings

    Product Note: Shingles is a viral infection (herpes zoster) of the skin with symptoms of rashes or blisters, redness and pain. Viral infections are often highly contagious.

    If skin symptoms worsen consult a health care professional.

    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.

    External use only. If accidental ingestion, get medical help or contact a Poison Control Center.

    Do not apply to the eyes or mucous membranes.

    Keep all medicines out of the reach of children.

    Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

  • PRINCIPAL DISPLAY PANEL - 11ml Bottle Label

    FORCES OF NATURE ®

    Shingles
    CONTROL
    EXTRA STRENGTH

    HOMEOPATHIC
    MEDICINE
     FDA REGISTERED
    +
    USDA
    ORGANIC

    11ml

    PRINCIPAL DISPLAY PANEL - 11ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SHINGLES CONTROL   EXTRA STRENGTH
    calendula officinalis flowering top, hypericum perforatum, and sodium chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51393-7323
    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
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 1000 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE8 [hp_X]  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51393-7323-111 mL in 1 BOTTLE, DISPENSING
    2NDC:51393-7323-233 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/06/2011
    Labeler - Forces of Nature (050169130)
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