Label: JOINT AND TENDON RESCUE (bryonia- alba, ruta graveolens, bellis perennis, capsicum annuum, ledum palustre, symphytum officinale, colchicum autumnale, rhododendron chrysanthum, argentum metallicum gel

  • NDC Code(s): 43846-0077-1
  • Packager: Peaceful Mountain, Inc.
  • 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 December 12, 2018

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

  • ACTIVE INGREDIENTS:

    (in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X

  • INDICATIONS:

    May temporarily relieve minor symptoms of joint pain and inflammation and tendon and soft tissue discomfort.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • 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 • Conditions worsens • Symptoms last more than 7 days

    Do not use if safety seal is broken or missing.

  • 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 at least 3 times daily over the affected area.

    Children under 12 years of age: Consult a doctor.

  • INDICATIONS:

    May temporarily relieve minor symptoms of joint pain and inflammation and tendon and soft tissue discomfort.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Sodium Hydroxide (Solution), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Tocopherols [Vitamin E Oil] (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Arnica (flower), Comfrey (leaf), White Willow (bark), Celery (seed), Devil’s Claw (root), Feverfew (leaf), Poke (root), Ascorbic Acid, Turmeric (Root).

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.
    Woodbine, IA 51579

    888-303-3388
    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    joint and tendon rescue
    peaceful mountain
    THE HEIGHT OF HEALTH
    homeopathic gel
    paraben-free
    formulated in
    boulder, co
    Net wt. 2 oz. (57 g)

    Joint and Tendon Rescue

  • INGREDIENTS AND APPEARANCE
    JOINT AND TENDON RESCUE 
    bryonia (alba), ruta graveolens, bellis perennis, capsicum annuum, ledum palustre, symphytum officinale, colchicum autumnale, rhododendron chrysanthum, argentum metallicum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0077
    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
    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
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 g
    WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY12 [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 LEAF30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OREGANO (UNII: 0E5AT8T16U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    CELERY SEED (UNII: 1G1EAA320L)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    FEVERFEW (UNII: Z64FK7P217)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TURMERIC (UNII: 856YO1Z64F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0077-157 g in 1 TUBE; Type 0: Not a Combination Product12/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/12/2018
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0077) , api manufacture(43846-0077) , label(43846-0077) , pack(43846-0077)