FDA.reportPublic FDA data

ITIRES

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2022-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:08

Label at a glance#

ProductITIRES
Active ingredientArnica montana Root, CALCIUM FLUORIDE, CALCIUM IODIDE, Clematis recta Flowering Top, SCROPHULARIA NODOSA WHOLE, Conium maculatum Flowering Top, HORSE CHESTNUT, Hedera helix Flowering Twig
Label structure9 sections

Indications and uses

Helps cleanse and detoxify the body

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

OTC - ACTIVE INGREDIENT SECTION

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

Selected ingredients prepared by spagyric processes.

UsesApplication 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 i...

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Helps cleanse and detoxify the body

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEKANA®

ITIRES™
Homeopathic Ointment

Helps cleanse and detoxify the body

1.2 OZ
35 g

PRINCIPAL DISPLAY PANEL - 35 g Tube Box
PRINCIPAL DISPLAY PANEL - 35 g Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-309-30ITIRES30 g in 1 TUBEOINTMENT303
59469-309-30ITIRES1 in 1 BOXOINTMENT13
59469-309-35ITIRES35 g in 1 TUBEOINTMENT353
59469-309-35ITIRES1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-309ITIRES (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]3Current NDC, Legacy NDC, 4 package rows20221224_8d93bb65-8021-4ef2-87a8-ee90ebd7dc06.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-30959469-309-35, 59469-309-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Arnica montana RootMUE8Y11327ACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALCIUM IODIDE8EKI9QEE2HACTIB
Clematis recta Flowering Top396421SP9FACTIB
SCROPHULARIA NODOSA WHOLE7H443NUB2TACTIB
Conium maculatum Flowering TopQ28R5GF371ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
Hedera helix Flowering Twig3D10KUA6BMACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Cetyl Alcohol936JST6JCNIACT
SPERMACETIP86KHA8V3KIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
Alcohol3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ITIRESARNICA MONTANA ROOT, CALCIUM FLUORIDE, CALCIUM IODIDE, CLEMATIS RECTA FLOWERING TOP, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, HORSE CHESTNUT, AND HEDERA HELIX FLOWERING TWIGPEKANA Naturheilmittel GmbH8d93bb65-8021-4ef2-87a8-ee90ebd7dc062022-12-23WarningsExact identifier
ndc (package): 59469-309-35
ndc (package): 59469-309-30
ndc (product): 59469-309
ndc11 (package): 59469030935
ndc11 (package): 59469030930
spl id: d5273f5c-c438-4f63-b7a6-fc209c1ff1c4
spl set id: 8d93bb65-8021-4ef2-87a8-ee90ebd7dc06

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.