Label: HOMEOPATHIC COLD AND CANKER SORE FORMULA- antimonum crudum, apis mellifica, cuprum metallicum, euphorbia lathyris, rhus toxicodendron tablet

  • 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 25, 2011

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  • ACTIVE INGREDIENT

    I n g r e d i e n t s :

    Antimony trisulfide........................ 10X HPUS
    Honeybee................................. 10X HPUS
    Copper.......................... 10X HPUS
    Gopher plant...........................10X HPUS
    Poison oak........................ 12X HPUS

    The letters “HPUS” indicate that the components in
    this product are officially monographed in the
    Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    For relief of cold and canker sores

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    For relief of cold and canker sores

  • WARNINGS

    Warning: If you are taking any medications or
    are pregnant or breast feeding do not use prior to
    consulting a physician.

  • DOSAGE & ADMINISTRATION


    Suggested Use: Adults and children over 12
    years, take 2 tablets. Dissolve under tongue or
    chew up to 4 times daily until symptoms subside,
    or as directed by a health professional. If
    symptoms persist for more than 7 days or worsen consult a
    health professional.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose, Magnesium
    Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057805290

    Homeopathic Cold and Canker Sore Formula

    For relief of cold and canker sores

    300 mg.
    90 Tablets


    image of label


  • USER SAFETY WARNINGS

    For your protection, this container has an outer
    safety seal. (Do not accept if missing or broken.)
    Best if used by date on bottle. Store in a dry cool place.
    Any Questions? 1-800-644-8327
    website: www.botanicchoice.com

  • SPL UNCLASSIFIED SECTION

    FDA Establishment #: 1811575

    Distributed by: Indiana Botanic Gardens, Inc.
    3401 W. 37th Ave. Hobart, IN 46342

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC COLD AND CANKER SORE FORMULA 
    antimonum crudum, apis mellifica, cuprum metallicum, euphorbia lathyris, rhus toxicodendron tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-052
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY TRISULFIDE10 [hp_X]
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER10 [hp_X]
    EUPHORBIA LATHYRIS (UNII: GHV7FV90K2) (EUPHORBIA LATHYRIS - UNII:GHV7FV90K2) EUPHORBIA LATHYRIS10 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code H;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-052-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/07/2010
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture
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