Label: ITIRES- arnica montana root, calcium fluoride, calcium iodide, clematis recta flowering top, scrophularia nodosa, conium maculatum flowering top, horse chestnut, and hedera helix flowering twig ointment

  • NDC Code(s): 59469-161-30, 59469-161-35
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 5, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients:
    Aesculus hippocastanum 4X
    Arnica montana 8X
    Calcium fluoratum 8X
    Calcium jodatum 6X
    Clematis recta 3X
    Conium maculatum 3X
    Hedera helix 6X
    Scrophularia nodosa 2X
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  • Inactive ingredients

    Purified water, cetyl alcohol, cetylstearyl alcohol, glycerol, synthetic cetaceum, triglycerides. Selected ingredients prepared by spagyric processes.

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  • Indications

    For support of lymphatic system. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

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  • Dosage

    Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into affected area. For external use only. Do not use on open wounds!

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  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

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  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®
    GmbH
    D-88353 Kisslegg

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  • PRINCIPAL DISPLAY PANEL - 35 g Tube Box

    PEKANA®

    ITIRES
    Homeopathic Ointment

    For support of lymphatic system

    PRINCIPAL DISPLAY PANEL - 35 g Tube Box
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  • INGREDIENTS AND APPEARANCE
    ITIRES 
    arnica montana root, calcium fluoride, calcium iodide, clematis recta flowering top, scrophularia nodosa, conium maculatum flowering top, horse chestnut, and hedera helix flowering twig ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-161
    Route of Administration CUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Arnica montana Root (UNII: MUE8Y11327) (Arnica montana Root - UNII:MUE8Y11327) Arnica montana Root 8 [hp_X]  in 35 g
    Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride 8 [hp_X]  in 35 g
    Calcium Iodide (UNII: 8EKI9QEE2H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Iodide 6 [hp_X]  in 35 g
    Clematis recta Flowering Top (UNII: 396421SP9F) (Clematis recta Flowering Top - UNII:396421SP9F) Clematis recta Flowering Top 3 [hp_X]  in 35 g
    Scrophularia nodosa (UNII: 7H443NUB2T) (Scrophularia nodosa - UNII:7H443NUB2T) Scrophularia nodosa 2 [hp_X]  in 35 g
    Conium maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium maculatum Flowering Top 3 [hp_X]  in 35 g
    Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut 4 [hp_X]  in 35 g
    Hedera helix Flowering Twig (UNII: 3D10KUA6BM) (Hedera helix Flowering Twig - UNII:3D10KUA6BM) Hedera helix Flowering Twig 6 [hp_X]  in 35 g
    Inactive Ingredients
    Ingredient Name Strength
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Spermaceti (UNII: P86KHA8V3K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59469-161-35 1 in 1 BOX 04/12/2008
    1 35 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:59469-161-30 1 in 1 BOX 04/12/2008
    2 30 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 04/12/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    Name Address ID/FEI Business Operations
    PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(59469-161)
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