Label: POLYGONUM- polygonum aviculare, acorus calamus, rhus toxicodendron, gnaphalium polycephalum, rhododendron chrysanthum, colocynthis, colchicum autumnale, kali iodatum, ichthyolum, symphytum officinale 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 November 23, 2011

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  • Active Ingredients

    Polygonum Aviculare 1x

    Acorus Calamus 1x

    Rhus Toxicodendron 4xHPUS

    Gnaphalium Polycephalum 2xHPUS

    Rhododendron Chrysanthum 3xHPUS

    Colocynthis 3xHPUS

    Colchicum Autumnale 3xHPUS

    Kali Iodatum 4xHPUS

    Ichthyolum 3xHPUS

    Symphytum Officinale 1XHPUS

    The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

    Purpose

    Relief of pain in joints and muscles.

    Keep out of reach of children.

    Suggested use

    Adults: take 30 drops in a glass of tepid water three to five times daily. For acute rheumatic symptoms, take 10 - 15 drops in waterevery hour. As maintenance take 30 drops two times daily. Children receive 1/2 or less of the adult amount.

    Warnings

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

    (Read Suggested Use Section)

    Inactive Ingredients

    Ethyl Alcohol (50.2% by vol.) and Water

  • PRINCIPAL DISPLAY PANEL


    label
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  • INGREDIENTS AND APPEARANCE
    POLYGONUM 
    polygonum aviculare, acorus calamus, rhus toxicodendron, gnaphalium polycephalum, rhododendron chrysanthum, colocynthis, colchicum autumnale, kali iodatum, ichthyolum, symphytum officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-1022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) (POLYGONUM AVICULARE TOP - UNII:ZCD6009IUF) POLYGONUM AVICULARE TOP1 [hp_X]  in 100 mL
    ACORUS CALAMUS WHOLE (UNII: Q46A6NDR5C) (ACORUS CALAMUS WHOLE - UNII:Q46A6NDR5C) ACORUS CALAMUS WHOLE1 [hp_X]  in 100 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 100 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM2 [hp_X]  in 100 mL
    RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF3 [hp_X]  in 100 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]  in 100 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB3 [hp_X]  in 100 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM IODIDE4 [hp_X]  in 100 mL
    ICHTHAMMOL (UNII: NQ14646378) (ICHTHAMMOL - UNII:NQ14646378) ICHTHAMMOL3 [hp_X]  in 100 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-1022-350 mL in 1 BOTTLE, GLASS
    2NDC:60986-1022-4100 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/1992
    Labeler - Marco Pharma International LLC. (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nestmann Pharma GmbH323426262manufacture