Label: FRANKINCENSE AND MYRRH NEUROPATHY - aconitum napellus, bryonia alba root and st. john's wort oil

  • NDC Code(s): 42346-300-59
  • Packager: Wise Consumer Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

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

  • ACTIVE INGREDIENTS

    ACONITUM NAPELLUS 3X

    BRYONIA ALBA 2X

    HYPERICUM 3X

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  • PURPOSE

    ACONITUM NAPELLUS 3X................PAIN RELIEF

    BRYONIA ALBA 2X..........................ANTI-INFLAMMATORY

    HYPERICUM 3X...............................TOPICAL ANALGESIC

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  • Uses:

    For temporary relief of the symptoms of neuropathy.

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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. 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 feet and ankles. Then cover area with sock. Can be used up to
    4 times daily. Pain will subside between 1 and 4 weeks.

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  • INACTIVE INGREDIENTS:

    BERGAMOT OIL, CINNAMON OIL, EUCALYPTUS OIL, FRANKINCENSE OIL,
    GERANIUM OIL, LEMON OIL, MYRRH OIL, NUTMEG 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. 42346-300-59


    Frankincense and Myrrh

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

    NEUROPATHY

    Homeopathic RUBBING OIL 2 FL OZ (59mL)

    Neuropathy Inner Label

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  • INGREDIENTS AND APPEARANCE
    FRANKINCENSE AND MYRRH NEUROPATHY  
    aconitum napellus 3x, bryonia alba 2x, hypericum 3x oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42346-300
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 2 [hp_X]  in 59 mL
    ST. JOHN'S WORT (ST. JOHN'S WORT) ST. JOHN'S WORT 3 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    BERGAMOT OIL  
    CINNAMON OIL  
    EUCALYPTUS OIL  
    FRANKINCENSE OIL  
    GERANIUM OIL, ALGERIAN TYPE  
    LEMON OIL  
    MYRRH OIL  
    NUTMEG OIL  
    PEPPERMINT OIL  
    ROSEMARY OIL  
    SUNFLOWER OIL  
    .ALPHA.-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42346-300-59 1 in 1 CARTON
    1 59 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/07/2009 07/01/2016
    Labeler - Wise Consumer Products (006459643)
    Establishment
    Name Address ID/FEI Business Operations
    PJ Noyes Co. Inc. 018927392 manufacture(42346-300)
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