Label: FIBROCANE RELIEF- symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gel

  • 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 23, 2014

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  • ACTIVE INGREDIENTS:

    Symphytum officinale 3X, Capsicum annuum 6X, Ledum palustre 6X, Colchicum autumnale 12X, Rhododendron chrysanthum 12X, Ruta graveolens 12X.

  • INDICATIONS:

    For temporary relief of minor symptoms of joint pain and inflammation.*

    *These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    For external use only.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

    When using this product do not get into eyes.

    Stop use and call a doctor if condition worsens or symptoms last more than 7 days.

    Consult a physician for use in children under 12 years of age.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Apply generously and rub thoroughly for 20-30 seconds over the affected area.  Flexing and releasing the affected muscles and joints after applying this product may enhance its ability to help you.  This process may be repeated several times a day.

  • INDICATIONS:

    For temporary relief of minor symptoms of joint pain and inflammation.*

    *These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Acrylates/C10-30 alkyl acrylate crosspolymer, Aloe barbadensis leaf juice, Arnica (flower), Ascorbic acid, Celery (seed), Comfrey leaf, Devil's Claw (root), Edate disodium (EDTA), Feverfew (leaf), Vitamin E, Oregano, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly glycol, Sorbic acid, Poke (root), Potassium sorbate, Purified Water, Sodium hydroxide, Turmeric (root), White willow (bark)

  • QUESTIONS:

    Distributed by Premier Bioceuticals LLC,

    P. O. BOX 78391

    Indianapolis, IN 46278

  • PACKAGE LABEL DISPLAY:

    Premier BIOCEUTICALS

    NDC 57850-2000-1

    FibroCane

    RELIEF

    For temporary relief of monor symptoms of joint pain and inflammation.

    Homeopathic Gel

    paraben-free

    Ner wt. 2 oz.  (57 g)

    FibroCane Relief

  • INGREDIENTS AND APPEARANCE
    FIBROCANE RELIEF 
    symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57850-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 g
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]  in 1 g
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 1 g
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB12 [hp_X]  in 1 g
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF12 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CELERY SEED (UNII: 1G1EAA320L)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FEVERFEW (UNII: Z64FK7P217)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    OREGANO (UNII: 0E5AT8T16U)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TURMERIC (UNII: 856YO1Z64F)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57850-2000-157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/17/2014
    Labeler - Premier Bioceuticals LLC (027714978)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(57850-2000) , api manufacture(57850-2000) , label(57850-2000) , pack(57850-2000)
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