Equisteum Iris by Uriel Pharmacy Inc. EQUISTEUM IRIS ointment

Equisteum Iris by

Drug Labeling and Warnings

Equisteum Iris by is a Homeopathic medication manufactured, distributed, or labeled by Uriel Pharmacy Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION

Apply to skin as needed. Under age 2: Consult a doctor.

ACTIVE INGREDIENT

Active Ingredients: Calendula 2X, Equisetum (Common horsetail) 2X, Iris 2X, Sulfur 2X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, Lanolin, Organic olive oil, Zinc oxide, Beeswax, Glyceryl monostearate, Stearyl alcohol, Geranium oil, Polyoxyl 40 stearate, Sorbic acid, Rose oil, Grapefruit seed extract

PURPOSE

Uses: Temporary relief of itching skin and diaper rash.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

QUESTIONS

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUISTEUM IRIS 
equisteum iris ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-4129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2 [hp_X]  in 1 g
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z)	EQUISETUM ARVENSE TOP	2 [hp_X]  in 1 g
C12-17 ALKANE (UNII: FW7807707B) (C12-17 ALKANE - UNII:FW7807707B)	C12-17 ALKANE	2 [hp_X]  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)
OLIVE OIL (UNII: 6UYK2W1W1E)
ZINC OXIDE (UNII: SOI2LOH54Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
ROSE OIL (UNII: WUB68Y35M7)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-4129-5	60 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2009

Labeler - Uriel Pharmacy Inc. (043471163)

Establishment
Name	Address	ID/FEI	Business Operations
Uriel Pharmacy Inc.		043471163	manufacture(48951-4129)