FDA.reportPublic FDA data

Echinacea Calendula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:01

Label at a glance#

ProductEchinacea Calendula
Active ingredientECHINACEA, UNSPECIFIED, CALENDULA OFFICINALIS FLOWERING TOP, LARIX DECIDUA RESIN, SUS SCROFA SKIN, VISCUM ALBUM FRUITING TOP, SUS SCROFA UMBILICAL CORD, BOS TAURUS PLACENTA, CUPRIC ACETATE, SILVER
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100gm contains: 30gm Echinacea (Purple coneflower) 1X, 15gm Calendula 1X, 0.5gm Resina laricis (Larch resin) 1X; Viscum Mali (Apple tree mistletoe) 3X, Cuprum aceticum (Copper acetate) 6X, Argentum metallicum (Silver) 7X, Cutis - feti (Porcine skin) 8X, Funiculus umbilicalis (Bovine umbilical cord) 8X, Placenta - bovis (Bovine placenta) 8X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spring water, Distilled water, Glycerin, Boric acid, Sodium alginate, Rosemary oil, Sodium hydroxide, Sorbic acid, Tea tree oil, Grapefruit seed extract, Lactose

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Soothes delicate skin, supports slowly healing wounds and strengthens skin regeneration.

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. Contains traces of lactose. 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.

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

Echinacea Calendula GelEchinacea Calendula Gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4175-5Echinacea Calendula60 g in 1 TUBEGEL604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4175ECHINACEA CALENDULA GEL [URIEL PHARMACY INC.]41 package rows20241123_06472efa-d150-d303-e063-6394a90a596b.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-417548951-4175-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
LARIX DECIDUA RESINAD8LJ73GQFACTIB
SUS SCROFA SKIN3EM4VW6TQNACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BORIC ACIDR57ZHV85D4IACT
CITRUS PARADISI SEED12F08874Y7IACT
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
SUS SCROFA UMBILICAL CORD118OYG6W3HACTIB
BOS TAURUS PLACENTA83AL37E3A7ACTIB
SODIUM ALGINATEC269C4G2ZQIACT
SORBIC ACIDX045WJ989BIACT
ROSEMARY OIL8LGU7VM393IACT
SODIUM HYDROXIDE55X04QC32IIACT
TEA TREE OILVIF565UC2GIACT
CUPRIC ACETATE39M11XPH03ACTIB
SILVER3M4G523W1GACTIB

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
27844324-6e24-b0ff-e063-6394a90ab36906472efa-d150-d303-e063-6394a90a596b2024-11-22WarningsExact identifier
spl id: 27844324-6e24-b0ff-e063-6394a90ab369
spl set id: 06472efa-d150-d303-e063-6394a90a596b

Reported adverse events (FAERS/openFDA)#

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