FDA.reportPublic FDA data

Arnica Echinacea

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:01

Label at a glance#

ProductArnica Echinacea
Active ingredientARNICA MONTANA FLOWER, HAMAMELIS VIRGINIANA TOP, ECHINACEA, UNSPECIFIED, COMFREY ROOT, CALENDULA OFFICINALIS FLOWERING TOP, BELLIS PERENNIS, ACONITUM NAPELLUS, CALCIUM SULFIDE, MERCURY, ACHILLEA MILLEFOLIUM, CHAMOMILE, ARNICA MONTANA, ATROPA BELLADONNA, ST. JOHN'S WORT
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: Arnica (Arnica e flor.) 3X, Bellis (Daisy) 5X, Echinacea (Purple coneflower) 5X, Hamamelis (Witch hazel) 5X, Hypericum (St. John’s Wort) 5X, Achillea (Yarrow) 6X, Aconitum (Monkshood) 6X, Arnica (e pl.tota) 6X, Atropa belladonna (Nightshade) 6X, Calendula (Calendula ex herba) 6X, Chamomilla (Chamomile) 6X, Hepar sulfuris (Liver of lime) 9X,
Symphytum (Comfrey) 9X, Mercurius vivus (Mercury amidonitrate) 9X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spring water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Distilled water, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil

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: 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 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

Arnica Echinacea CreamArnica Echinacea Cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1362-5Arnica Echinacea60 g in 1 TUBECREAM603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1362ARNICA ECHINACEA CREAM [URIEL PHARMACY, INC.]31 package rows20241123_05b85d50-0e3e-4365-e063-6294a90a3782.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-136248951-1362-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBIC ACIDX045WJ989BIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
FRANKINCENSE OIL67ZYA5T02KIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TEA TREE OILVIF565UC2GIACT
MYRRH OILH74221J5J4IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
HAMAMELIS VIRGINIANA TOPUDA30A2JJYACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
WATER059QF0KO0RIACT
COMFREY ROOTM9VVZ08EKQACTIB
LAVENDER OILZBP1YXW0H8IACT
CITRUS PARADISI SEED12F08874Y7IACT
CETYL ALCOHOL936JST6JCNIACT
XANTHAN GUMTTV12P4NEEIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
BELLIS PERENNIS2HU33I03UYACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
MERCURYFXS1BY2PGLACTIB
STEARIC ACID4ELV7Z65APIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
CHAMOMILEFGL3685T2XACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ST. JOHN'S WORTUFH8805FKAACTIB

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
278525b8-2576-58e7-e063-6294a90ad46805b85d50-0e3e-4365-e063-6294a90a37822024-11-22WarningsExact identifier
spl id: 278525b8-2576-58e7-e063-6294a90ad468
spl set id: 05b85d50-0e3e-4365-e063-6294a90a3782

Reported adverse events (FAERS/openFDA)#

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