Label: JOINT TONIC R II- harpagophytum procumbens, salix alba, colchicum autumnale, pinus sylvestris, symphytum officinale, aconitum napellus, arnica montana, gelsemium sempervirens, iris versicolor, ledum palustre, lespedeza capitata, rhus tox, secale cornutum, spigelia anthelmia, spiraea ulmaria, tartaricum acidum 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 May 20, 2021

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  • ACTIVE INGREDIENTS:

    Harpagophytum Procumbens MT, Salix Alba MT, Colchicum Autumnale 3X, Pinus Sylvestris 6X, Symphytum Officinale 6X, Aconitum Napellus 12X, Arnica Montana 12X, Gelsemium Sempervirens 12X, Iris Versicolor 12X, Ledum Palustre 12X, Lespedeza Capitata 12X, Rhus Tox 12X, Secale Cornutum 12X, Spigelia Anthelmia 12X, Spiraea Ulmaria 12X, Tartaricum Acidum 12X.

  • INDICATIONS:

    For temporary relief of symptoms due to swelling of wrist, pain and swelling of knees, joints red and swollen, and hot pain in the big toe.

  • WARNINGS:

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of symptoms due to swelling of wrist, pain and swelling of knees, joints red and swollen, and hot pain in the big toe.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    JOINT TONIC R II

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Joint Tonic R II

  • INGREDIENTS AND APPEARANCE
    JOINT TONIC R  II
    harpagophytum procumbens, salix alba, colchicum autumnale, pinus sylvestris, symphytum officinale, aconitum napellus, arnica montana, gelsemium sempervirens, iris versicolor, ledum palustre, lespedeza capitata, rhus tox, secale cornutum, spigelia anthelmia, spiraea ulmaria, tartaricum acidum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0588
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89) HARPAGOPHYTUM PROCUMBENS ROOT1 [hp_X]  in 1 mL
    SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7) SALIX ALBA BARK1 [hp_X]  in 1 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB3 [hp_X]  in 1 mL
    PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS LEAFY TWIG - UNII:Q1RGP4UB73) PINUS SYLVESTRIS LEAFY TWIG6 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE12 [hp_X]  in 1 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE12 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT12 [hp_X]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]  in 1 mL
    LESPEDEZA CAPITATA FLOWERING TOP (UNII: F930LFZ4LF) (LESPEDEZA CAPITATA FLOWERING TOP - UNII:F930LFZ4LF) LESPEDEZA CAPITATA FLOWERING TOP12 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM12 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE12 [hp_X]  in 1 mL
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT12 [hp_X]  in 1 mL
    TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H) TARTARIC ACID12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0588-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/20/2021
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0588) , api manufacture(43857-0588) , label(43857-0588) , pack(43857-0588)
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