FDA.reportPublic FDA data

Arnica Cepa Symphytum

Manufacturer
Uriel Pharmacy, Inc
Effective date
2025-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:30:04

Label at a glance#

ProductArnica Cepa Symphytum
Active ingredientCOMFREY ROOT, ONION, ARNICA MONTANA
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: 2gm Allium cepa (Onion) 1X, 5gm Arnica montana 1X, 3gm Symphytum ex herba (Comfrey) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic olive oil, Lanolin, Sunflower seed oil, Spring water, Yellow beeswax, Lanolin alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Temporary relief of bruises, sprains, and minor cuts.

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 seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Cepa Symphytum OintmentArnica Cepa Symphytum 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
48951-1390-2Arnica Cepa Symphytum30 g in 1 TUBEOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1390ARNICA CEPA SYMPHYTUM OINTMENT [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250105_2ad4a274-1f46-7f85-e063-6394a90a4d67.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
48951-139048951-1390-2

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
COMFREY ROOTM9VVZ08EKQACTIB
BEESWAX2ZA36H0S2VIACT
ONION492225Q21HACTIB
LANOLIN ALCOHOL884C3FA9HEIACT
ARNICA MONTANAO80TY208ZWACTIB
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
LANOLIN7EV65EAW6HIACT
WATER059QF0KO0RIACT

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
Arnica Cepa SymphytumARNICA CEPA SYMPHYTUMUriel Pharmacy, Inc2ad4a274-1f46-7f85-e063-6394a90a4d672025-01-03WarningsExact identifier
ndc (package): 48951-1390-2
ndc (product): 48951-1390
ndc11 (package): 48951139002
spl id: 2ad4a274-1f47-7f85-e063-6394a90a4d67
spl set id: 2ad4a274-1f46-7f85-e063-6394a90a4d67

Reported adverse events (FAERS/openFDA)#

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