Label: ITIRES- barium carbonate, calcium iodide, helianthemum canadense, conium maculatum flowering top, scrophularia nodosa, echinacea, unspecified, galium aparine, and juglans regia whole solution/ drops

  • NDC Code(s): 59469-112-10, 59469-112-30
  • 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 June 20, 2019

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

  • ACTIVE INGREDIENT

    Ingredients:
    Barium carbonicum 8X
    Calcium jodatum 8X
    Helianthemum canadense (Cistus canadensis) 12X
    Conium maculatum 6X
    Echinacea angustifolia 12X
    Galium aparine 6X
    Juglans regia 6X
    Scrophularia nodosa 4X

    Selected ingredients prepared by spagyric processes.

    Close
  • INACTIVE INGREDIENT

    Contains 18% alcohol by volume.

    Close
  • Indications

    Helps cleanse and detoxify the body. 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.

    Close
  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

    Close
  • 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.

    Close
  • Tamper Evident

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

    Close
  • QUESTIONS

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

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®
    GmbH
    D-88353 Kisslegg

    Close
  • PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box

    ITIRES™
    Oral Drops

    Homeopathic Medicine

    Helps cleanse and
    detoxify the body

    3.34 FL OZ
    (100 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
    Close
  • INGREDIENTS AND APPEARANCE
    ITIRES 
    barium carbonate, calcium iodide, helianthemum canadense, conium maculatum flowering top, scrophularia nodosa, echinacea, unspecified, galium aparine, and juglans regia whole solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-112
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Barium Carbonate (UNII: 6P669D8HQ8) (Barium cation - UNII:V645272HLN) Barium Carbonate 8 [hp_X]  in 50 mL
    Calcium Iodide (UNII: 8EKI9QEE2H) (Calcium cation - UNII:2M83C4R6ZB) Calcium Iodide 8 [hp_X]  in 50 mL
    Helianthemum canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum canadense 12 [hp_X]  in 50 mL
    Conium maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium maculatum Flowering Top 6 [hp_X]  in 50 mL
    Scrophularia nodosa (UNII: 7H443NUB2T) (Scrophularia nodosa - UNII:7H443NUB2T) Scrophularia nodosa 4 [hp_X]  in 50 mL
    Echinacea, unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, unspecified 12 [hp_X]  in 50 mL
    Galium Aparine (UNII: Z4B6561488) (Galium Aparine - UNII:Z4B6561488) Galium Aparine 6 [hp_X]  in 50 mL
    Juglans regia Whole (UNII: 87EJ76IO83) (Juglans regia Whole - UNII:87EJ76IO83) Juglans regia Whole 6 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59469-112-10 1 in 1 BOX 12/11/2008
    1 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2 NDC:59469-112-30 1 in 1 BOX 12/11/2008
    2 100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 12/11/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    Name Address ID/FEI Business Operations
    PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(59469-112)
    Close