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): 59469-309-30, 59469-309-35
  • 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, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug facts

  • ACTIVE INGREDIENT

    Active ingredients
    Aesculus hippocastanum4X
    Arnica montana8X
    Calcium fluoratum8X
    Calcium jodatum6X
    Clematis recta4X
    Conium maculatum6X
    Hedera helix6X
    Scrophularia nodosa2X

    Selected ingredients prepared by spagyric processes.

  • Uses1

    Helps cleanse and detoxify the body


    1
    Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. These "Uses" have not been evaluated by the Food and Drug Administration. With severe forms of this disease, a clinically proven therapy is indicated.
  • Warnings

    For external use only. Do not use on open wounds! 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.

  • Directions

    Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.

  • Other information

    Protect from light and heat.

    Tamper Evident

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

  • Inactive ingredients

    Purified water, cetyl alcohol, cetylstearyl alcohol, glycerol, synthetic cetaceum, triglycerides.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    PEKANA® GmbH
    D-88353 Kisslegg

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 35 g Tube Box

    PEKANA®

    ITIRES™
    Homeopathic Ointment

    Helps cleanse and detoxify the body

    1.2 OZ
    35 g

    PRINCIPAL DISPLAY PANEL - 35 g Tube Box
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-309
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arnica montana Root (UNII: MUE8Y11327) (Arnica montana Root - UNII:MUE8Y11327) Arnica montana Root8 [hp_X]  in 35 g
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE8 [hp_X]  in 35 g
    CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE6 [hp_X]  in 35 g
    Clematis recta Flowering Top (UNII: 396421SP9F) (Clematis recta Flowering Top - UNII:396421SP9F) Clematis recta Flowering Top4 [hp_X]  in 35 g
    Scrophularia nodosa (UNII: 7H443NUB2T) (Scrophularia nodosa - UNII:7H443NUB2T) Scrophularia nodosa2 [hp_X]  in 35 g
    Conium maculatum Flowering Top (UNII: Q28R5GF371) (Conium maculatum Flowering Top - UNII:Q28R5GF371) Conium maculatum Flowering Top6 [hp_X]  in 35 g
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT4 [hp_X]  in 35 g
    Hedera helix Flowering Twig (UNII: 3D10KUA6BM) (Hedera helix Flowering Twig - UNII:3D10KUA6BM) Hedera helix Flowering Twig6 [hp_X]  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-309-351 in 1 BOX06/24/2019
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:59469-309-301 in 1 BOX06/24/2019
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/24/2019
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-309)