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™

Drug facts

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.

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
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 WHOLE (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA WHOLE - UNII:7H443NUB2T) SCROPHULARIA NODOSA WHOLE2 [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)

Revised: 12/2022
Document Id: d5273f5c-c438-4f63-b7a6-fc209c1ff1c4
Set id: 8d93bb65-8021-4ef2-87a8-ee90ebd7dc06
Version: 3
Effective Time: 20221223
 
PEKANA Naturheilmittel GmbH