FDA.reportPublic FDA data

Calendula Thuja

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:25:50

Label at a glance#

ProductCalendula Thuja
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA, UNSPECIFIED, ORIGANUM MAJORANA WHOLE, LILIUM LANCIFOLIUM WHOLE FLOWERING, THUJA OCCIDENTALIS WHOLE, WOOD CREOSOTE, PULSATILLA VULGARIS, SILVER, CANDIDA ALBICANS
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Under age 2: Consult a doctor.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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) 30X

INACTIVE INGREDIENT SECTION

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

"prepared using rhythmical processes"

OTC - PURPOSE SECTION

Use: Temporary relief of vaginal itching and irritation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calendula Thuja gelCalendula Thuja gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3253-8Calendula Thuja120 g in 1 TUBE, WITH APPLICATORGEL1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3253CALENDULA THUJA GEL [URIEL PHARMACY INC.]61 package rows20240127_06318bbd-9c05-921f-e063-6294a90a9077.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-325348951-3253-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
CITRUS PARADISI SEED12F08874Y7IACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ORIGANUM MAJORANA WHOLER40XM3HU5XACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
THUJA OCCIDENTALIS WHOLE5HBV6WCE3NACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SILVER3M4G523W1GACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
LACTIC ACID33X04XA5ATIACT
EUCALYPTUS OIL2R04ONI662IACT
ROSEMARY OIL8LGU7VM393IACT
SAGE OILU27K0H1H2OIACT
THYME OIL2UK410MY6BIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
0fa3f96d-3328-9344-e063-6294a90a181606318bbd-9c05-921f-e063-6294a90a90772024-01-23WarningsExact identifier
spl id: 0fa3f96d-3328-9344-e063-6294a90a1816
spl set id: 06318bbd-9c05-921f-e063-6294a90a9077

Reported adverse events (FAERS/openFDA)#

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