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 hippocastanum4X
Arnica montana8X
Calcium fluoratum8X
Calcium jodatum6X
Clematis recta3X
Conium maculatum3X
Hedera helix6X
Scrophularia nodosa2X

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

PRINCIPAL DISPLAY PANEL - 35 g Tube Box
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: 59469-161
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 Top3 [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 Top3 [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: 59469-161-351 in 1 BOX04/12/200806/30/2019
135 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 59469-161-301 in 1 BOX04/12/200806/30/2019
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC04/12/200806/30/2019
Labeler - PEKANA Naturheilmittel GmbH (320344542)

Revised: 11/2019
 
PEKANA Naturheilmittel GmbH