Label: FRANKINCENSE AND MYRRH FIBROMYALGIA - aconitum napellus, bryonia alba, geranium maculatum, hypericum oil

  • NDC Code(s): 42346-400-59
  • Packager: Wise Consumer Products
  • 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 May 15, 2013

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

  • ACTIVE INGREDIENTS

    ACONITUM NAPELLUS 3X
    BRYONIA ALBA 2X
    GERANIUM MACULATUM 2X
    HYPERICUM 3X

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  • PURPOSE

    ACONITUM NAPELLUS 3X................PAIN RELIEF
    BRYONIA ALBA 2X...........................ANTI-INFLAMMATORY
    GERANIUM MACULATUM 2X............HEADACHE RELIEF
    HYPERICUM 3X................................TOPICAL ANALGESIC

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  • Uses:

    For temporary relief of the symptoms of fibromyalgia.

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  • WARNINGS:

     FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

    DO NOT USE BY MOUTH, IN NOSTRILS, ON WOUNDS, OR DAMAGED SKIN.

    IF PREGNANT, BREASTFEEDING, OR ON A MEDICATION ASK A HEALTH CARE PROFESSIONAL BEFORE
    USE.

    DISCONTINUE USE IF SKIN IRRITATION DEVELOPS. NERVE PAIN IN THE FEET AND HANDS THAT INCLUDES BURNING,
    SHOOTING, PRICKLING/TINGLING PAINS, NUMBNESS OR ITCHING CAN BE SIGNS OF DIABETIC NEUROPATHY OR SYMPTOMS
    OF DEPRESSION. SEE A HEALTHCARE PROFESSIONAL REGULARLY IF YOU HAVE THESE SYMPTOMS OR SUSPECT THESE
    SYMPTOMS.

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CALL A POISON CONTROL CENTER RIGHT AWAY.

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  • DIRECTIONS:

    Adults apply 10-30 drops into palm of hand and massage onto areas that are causing pain.
    The oils could cause staining to some clothes, do not let excess rub off onto clothes. Can be used up to
    4 times daily. Pain will subside between 1 and 4 weeks.

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  • INACTIVE INGREDIENTS:

    EUCALYPTUS OIL, FRANKINCENSE OIL, GERANIUM OIL, LEMON OIL, MYRRH OIL, PEPPERMINT OIL, ROSEMARY OIL,
    SUNFLOWER OIL, VITAMIN E.

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  • DESCRIPTION

    Do not use if TAMPER EVIDENT seal around neck of bottle is broken or missing.

    Manufactured for: Wise Consumer Products Co.
    PO Box 42400, Cincinnati, OH 45242
    www.frankincensemyrrh.com

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  • Principal Display Panel

    NDC. 42346-400-59

    Frankincense and Myrrh

    Temporary Pain Relief - All Natural - Analgesic - Anti-Inflammatory

    FIBROMYALGIA

    Homeopathic RUBBING OIL 2 FL OZ (59mL)

    Fibromyalgia Inner Label

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  • INGREDIENTS AND APPEARANCE
    FRANKINCENSE AND MYRRH FIBROMYALGIA 
    aconitum napellus, bryonia alba, geranium maculatum, hypericum oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42346-400
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 2 [hp_X]  in 59 mL
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ) GERANIUM MACULATUM ROOT 2 [hp_X]  in 59 mL
    ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT 3 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    LEMON OIL (UNII: I9GRO824LL)  
    MYRRH OIL (UNII: H74221J5J4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42346-400-59 1 in 1 CARTON
    1 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/01/2009
    Labeler - Wise Consumer Products (006459643)
    Establishment
    Name Address ID/FEI Business Operations
    PJ Noyes co. Inc. 018927392 manufacture(42346-400)
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