FDA.reportPublic FDA data

Arnica Rosa

Manufacturer
Uriel Pharmacy Inc.
Effective date
2019-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:06:38

Label at a glance#

ProductArnica Rosa
Active ingredientBOS TAURUS BRAIN, ARNICA MONTANA, BOS TAURUS NERVE, BOS TAURUS EYE, SILICON DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Nervus opticus (Bovine second cranial nerve) 6X, Retina et chorioidea (Bovine retina and choroid) 6X, Corpara quadrigemina (Bovine quadrigeminal plate) 7X, Nervus oculomotorius (Bovine third cranial nerve) 8X, Arnica 17X, Chrysolith (Silicate of magnesium and iron) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt, Boric acid, Sodium bicarbonate, Rose oil

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN.
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 or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

REFRIGERATE AFTER OPENING. USE WITHIN 30 DAYS OF OPENING.
Opened on:_________________

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Rosa 10ml BagArnica Rosa 10ml BagArnica Rose 10mlArnica Rose 10ml

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-132748951-1327-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSE OILWUB68Y35M7IACT
BORIC ACIDR57ZHV85D4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BICARBONATE8MDF5V39QOIACT
BOS TAURUS BRAINA1YEE2DB8ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
BOS TAURUS NERVE28G2U3MQJKACTIB
BOS TAURUS EYEVTW461N43PACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
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
14a87155-dd79-893b-e063-6394a90a293d953266cc-52ed-1c4a-e053-2995a90a43722024-03-27WarningsExact identifier
spl set id: 953266cc-52ed-1c4a-e053-2995a90a4372

Reported adverse events (FAERS/openFDA)#

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