Calendula Thuja by Uriel Pharmacy Inc. CALENDULA THUJA gel

Calendula Thuja by

Drug Labeling and Warnings

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

Drug Details [pdf]

INDICATIONS & USAGE

Under age 2: Consult a doctor.

DOSAGE & ADMINISTRATION

Directions: Fill the provided applicator with 2 to 3 grams of gel and apply at bedtime for 14 nights.

ACTIVE INGREDIENT

Active Ingredients: Calendula 2X, Echinacea (Purple coneflower) 2X, Marjorana (Marjoram) 2X, Lilium tigrinum (Tiger lily) 3X, Thuja (American arborvitae) 3X, Kreosotum (Creosote) 6X, Pulsatilla (Pasqueflower) 6X, Argentum colloidal (Colloidal silver) 7X, Candida albicans (Yeast) 33X

INACTIVE INGREDIENT

Inactive Ingredients: Distilled water, Glycerin, Sodium alginate, Lactic acid, Eucalyptus oil, Rosemary oil, Sage oil, Thyme oil, Tea tree oil, Grapefruit seed extract

PURPOSE

Use: Temporary relief of vaginal itching and irritation.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

WARNINGS

Warnings: 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 seals on box are broken or missing. BEST WHEN USED WITHIN 30 DAYS OF OPENING.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALENDULA THUJA 
calendula thuja gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48951-3204
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
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	2 [hp_X]  in 1 g
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X) (ORIGANUM MAJORANA WHOLE - UNII:R40XM3HU5X)	ORIGANUM MAJORANA WHOLE	2 [hp_X]  in 1 g
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	3 [hp_X]  in 1 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	3 [hp_X]  in 1 g
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	6 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]  in 1 g
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	7 [hp_X]  in 1 g
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	33 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRUS PARADISI SEED (UNII: 12F08874Y7)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
LACTIC ACID (UNII: 33X04XA5AT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ROSEMARY OIL (UNII: 8LGU7VM393)
SAGE OIL (UNII: U27K0H1H2O)
THYME OIL (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48951-3204-8	120 g in 1 TUBE, WITH APPLICATOR; 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(48951-3204)