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

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]

SPL UNCLASSIFIED SECTION

Drug facts

ACTIVE INGREDIENT

Active ingredients
Aesculus hippocastanum	4X
Arnica montana	8X
Calcium fluoratum	8X
Calcium jodatum	6X
Clematis recta	4X
Conium maculatum	6X
Hedera helix	6X
Scrophularia nodosa	2X

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59469-309
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	4 [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	6 [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: 59469-309-35	1 in 1 BOX	06/24/2019
1		35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59469-309-30	1 in 1 BOX	06/24/2019
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		06/24/2019

Labeler - PEKANA Naturheilmittel GmbH (320344542)

Establishment
Name	Address	ID/FEI	Business Operations
PEKANA Naturheilmittel GmbH		320344542	MANUFACTURE(59469-309)