GRAPHITIS GLOBULE [TRUE BOTANICA, LLC]

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GRAPHITIS GLOBULE [TRUE BOTANICA, LLC]
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NDC 53645-1670-2
Set ID 61952fe1-813f-ff6e-e053-2a91aa0a2d58
Category HUMAN OTC DRUG LABEL
Packager True Botanica, LLC
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Graphites 30X, HPUS

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    For temporary relief of over sensitivity, constipation. May also be used for standard homeopathic indications or as directed by your physician.

  • Use:

    For temporary relief of over sensitivity, constipation. May also be used for standard homeopathic indications or as directed by your physician.

  • Warnings:

    Consult your health care provider if symptoms persist more than 5 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DO NOT USE

    TAMPER EVIDENT: Do not use if safety seal is broken before first use.

  • Directions for Use:

    Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

  • Other Ingredients:

    Sucrose

  • QUESTIONS

    Developed and Made by

    True Botanica, LLC

    1005 Richards Rd., Suite D

    Hartland, WI 53029

    800-315-8783

    www.truebotanica.com

  • Principal Display Panel

    Graphites 30X

  • INGREDIENTS AND APPEARANCE
    GRAPHITIS 
    graphitis globule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53645-1670
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE30 [hp_X]  in 23 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53645-1670-223 g in 1 BOTTLE; Type 0: Not a Combination Product02/03/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/03/2014
    Labeler - True Botanica, LLC (182071519)
    Establishment
    NameAddressID/FEIBusiness Operations
    True Botanica, LLC182071519manufacture(53645-1670)
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