ITIRES by PEKANA Naturheilmittel GmbH ITIRES™

ITIRES by

Drug Labeling and Warnings

ITIRES by is a Homeopathic medication manufactured, distributed, or labeled by PEKANA Naturheilmittel GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
PEKANA Naturheilmittel GmbH

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.

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ITIRES™

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

Inactive ingredients

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

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.

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!

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.

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

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 35 g Tube Box

PEKANA®

ITIRES™
Homeopathic Ointment

For support of lymphatic system

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	06/30/2019
1		35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59469-161-30	1 in 1 BOX	04/12/2008	06/30/2019
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	06/30/2019

Labeler - PEKANA Naturheilmittel GmbH (320344542)

Revised: 11/2019

Document Id: f39df626-642e-447a-a712-9d56d1217389

34390-5

Set id: 62b1890d-6ff0-4ccd-8296-d3fad66176e6

Version: 5

Effective Time: 20191115

 

PEKANA Naturheilmittel GmbH