Label: TENDON RESCUE- bryonia, ruta graveolens, bellis perennis, argentum metallicum 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 March 19, 2013

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

  • ACTIVE INGREDIENTS

    Bryonia 3X, 12X, Ruta Graveolens 3X, 12X, Bellis Perennis 6X, Argentum Metallicum 30X

  • INDICATIONS

    For temporary relief of symptoms of tendon and soft tissue discomfort.

  • 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 ask a doctor if Conidition worsens Symptoms last more than 7 days.

  • DIRECTIONS

    Apply at least 3 times daily over the affected area.  Consult a physician for use in children under 12 years of age. 

  • INACTIVE INGREDIENTS

    Aloe Vera, Arnica Montana (flower), Carbomer (Ultrez 21), Comfrey (leaf), Edetate Disodium, Origanox WS, PEG 33, PEG 8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Water, Rosemary (leaf), Sodium Hydroxide Solution, Ascorbic Acid, Vitamin E Oil

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS AND USAGE

    For temporary relief of symptoms of tendon and soft tissue discomfort.

  • QUESTIONS

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA  51579

    888-303-3388

    www.peacefulmountain.com

  • PRINCIPAL DISPLAY PANEL

    tendon rescue

    organic and wild-crafted herbs

    peaceful mountain

    THE HEIGHT OF HEALTH

    homeopathic gel

    paraben-free

    formulated in boulder, co

    Net wt. 3.7 oz (105 g)

    Tendon Rescue

  • INGREDIENTS AND APPEARANCE
    TENDON RESCUE 
    bryonia, ruta graveolens, bellis perennis, argentum metallicum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 1 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]  in 1 g
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS6 [hp_X]  in 1 g
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0006-1105 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/19/2013
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0006)