Calendula Essence

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:14

Label at a glance#

ProductCalendula Essence
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

For compresses: Use 2 teaspoons per cup of lukewarm water. For full bath: Use 2-3 tablespoons.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 100 gm contains: 20 gm Calendula 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

OTC - PURPOSE SECTION

Uses: For cuts, grazes and wounds, clean with a solution of Calendula Healing Essence. May use for cleansing sensitive or troubled skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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 if 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.

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

Calendula Essence LiquidCalendula Essence Liquid

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-3256-62026-01-29C16284748780-149896155-a5be-586f-e063-e6dba90add90Calendula Essence

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3256-6Calendula Essence125 mL in 1 BOTTLE, GLASSLIQUID1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3256CALENDULA ESSENCE LIQUID [URIEL PHARMACY INC.]21 package rows20241204_0a5b97e6-5a9d-ee99-e063-6294a90a1648.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-325648951-3256-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
284d8dc6-a3e5-285c-e063-6394a90ae3160a5b97e6-5a9d-ee99-e063-6294a90a16482024-12-02WarningsExact identifier
spl id: 284d8dc6-a3e5-285c-e063-6394a90ae316
spl set id: 0a5b97e6-5a9d-ee99-e063-6294a90a1648

Reported adverse events (FAERS/openFDA)#

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