FDA.reportPublic FDA data

Argentum Calendula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2023-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:18

Label at a glance#

ProductArgentum Calendula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, SLOE, SILVER, BOS TAURUS OVARY
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION


Directions: FOR VAGINAL USE.

DOSAGE & ADMINISTRATION SECTION

Fill the provided applicator with 2 to 3 grams of ointment and apply as needed.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Calendula 1X, Prunus spinosa (Blackthorn) 2X, Argentum met. (Silver) 3X, Ovaria (Bovine ovaries) 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic olive oil, Lanolin, Beeswax, Glycerin, Grapefruit seed extract

OTC - PURPOSE SECTION

Use: Temporary relief of vaginal dryness.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: 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 Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Argentum Calendula OintmentArgentum Calendula Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1364-5Argentum Calendula60 g in 1 TUBE, WITH APPLICATOROINTMENT601
48951-1364-5Argentum Calendula1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1364ARGENTUM CALENDULA OINTMENT [URIEL PHARMACY INC.]12 package rows20230923_05f590d0-511b-a6d7-e063-6394a90a93dd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-136448951-1364-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
CITRUS PARADISI SEED12F08874Y7IACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
SLOE3MLB4858X7ACTIB
SILVER3M4G523W1GACTIB
BOS TAURUS OVARY66LZN1C747ACTIB

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
05f59510-8570-6889-e063-6294a90ac14705f590d0-511b-a6d7-e063-6394a90a93dd2023-09-22WarningsExact identifier
spl id: 05f59510-8570-6889-e063-6294a90ac147
spl set id: 05f590d0-511b-a6d7-e063-6394a90a93dd

Reported adverse events (FAERS/openFDA)#

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