Label: FORMULA 8- arnica montana, bellis perennis, hypericum perforatum liquid

  • 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 June 25, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Arnica Montana 6C, Bellis Perennis 6C, Hypericum Perforatum 12C, Phosphorus 30C, Rhus Toxicodendron.

  • PURPOSE

    INDICATIONS:  For the temporary relief of pain and inflammation associated with injuries, muscle spasms and pulls, bruises, and trauma.


  • WARNINGS

    WARNINGS:  Keep out of reach of children.  In case of overdose, contact physician or Poison Control Center right away.

    If pregnant or breast-feeding, seek advice of a health professional before use.

    Tamper seal:  "Sealed for your protection."  Do not use if seal is broken or missing.


  • DOSAGE & ADMINISTRATION

    DIRECTIONS:    10 drops under the tongue, 3 times a day or as directed by a health professional.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized Water, 25% Ethanol

  • QUESTIONS


    Dist. By:

    Deseret Biologicals, Inc.

    469 Parkland Drive

    Sandy, UT 84070

    www.desbio.com

  • PRINCIPAL DISPLAY PANEL

    Deseret Biologicals Incorporated

    HOMEOPATHIC

    FORMULA #8

    33.8 FL OZ (1000 ML)

    Formula 8

  • INGREDIENTS AND APPEARANCE
    FORMULA 8 
    arnica montana, bellis perennis, hypericum perforatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_C]  in 1 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_C]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM12 [hp_C]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_C]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0201-11000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/29/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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