FDA.reportPublic FDA data

Arnica Hypericum DKS

Manufacturer
Uriel Pharmacy, Inc. | Arnica Hypericum DKS
Effective date
2021-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:47

Label at a glance#

ProductArnica Hypericum DKS
Active ingredientURTICA DIOICA, SEDUM ROSEUM WHOLE, ARNICA MONTANA FLOWER, GOLD, PENOXSULAM, ACONITUM NAPELLUS, OXALIS STRICTA WHOLE, ANTIMONY, 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 Ingredient: Hypericum (St. John’s Wort) 5X/10X, Aconitum (Monkshood) 6X, Aurum met. (Metallic gold) 6X, Oxalis (Wood sorrel) 6X, Stibium met. (Antimony) 6X, Urtica dioica (Stinging nettle) 6X, Arnica 6X/12X, Granite (Primitive rock containing quartz, feldspar, mica) 12X, Rosa (Garden rose) 6X/15X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic olive oil, Lanolin, Beeswax, Distilled water, Sunflower seed oil, Sorbic acid, Tea tree oil, Grapefruit seed extract, Lactose

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

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. Contains traces of lactose. 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
www.urielpharmacy.com Lot#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Hypericum DKS OintmentArnica Hypericum DKS 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
48951-1350-5Arnica Hypericum DKS60 g in 1 TUBEOINTMENT601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1350ARNICA HYPERICUM DKS OINTMENT [URIEL PHARMACY, INC.]1Legacy NDC, 1 package rows20210811_c8c1e7ab-5476-ffb2-e053-2995a90ae1fb.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-135048951-1350-5

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
CITRUS PARADISI SEED12F08874Y7IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
URTICA DIOICA710FLW4U46ACTIB
SEDUM ROSEUM WHOLERH0WP583U3ACTIB
OLIVE OIL6UYK2W1W1EIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
SUNFLOWER OIL3W1JG795YIIACT
SORBIC ACIDX045WJ989BIACT
GOLD79Y1949PYOACTIB
PENOXSULAM784ELC1SCZACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
OXALIS STRICTA WHOLE3STW243384ACTIB
ANTIMONY9IT35J3UV3ACTIB
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
c8c1e7ab-5477-ffb2-e053-2995a90ae1fbc8c1e7ab-5476-ffb2-e053-2995a90ae1fb2021-08-04WarningsExact identifier
spl id: c8c1e7ab-5477-ffb2-e053-2995a90ae1fb
spl set id: c8c1e7ab-5476-ffb2-e053-2995a90ae1fb

Reported adverse events (FAERS/openFDA)#

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