FDA.reportPublic FDA data

Arnica 20%

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:30

Label at a glance#

ProductArnica 20%
Active ingredientARNICA MONTANA FLOWER
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: 100 gm contains: 20 gm Arnica 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spring water, Organic cane alcohol, Glycerin, Boric acid, Sodium alginate, Lavender oil, Sorbic acid, Tea tree oil, Sodium hydroxide, Grapefruit seed extract

OTC - PURPOSE SECTION

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

prepared using rhythmical processes

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 20 GelArnica 20 Gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-1374-52026-01-29C16284748780-149896155-b04d-586f-e063-e6dba90add90Arnica 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1374-5Arnica 20%60 g in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1374ARNICA 20% GEL [URIEL PHARMACY INC.]11 package rows20240329_14bb1e99-7aa1-b0b7-e063-6394a90a2443.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-137448951-1374-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ALGINATEC269C4G2ZQIACT
CITRUS PARADISI SEED12F08874Y7IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
SORBIC ACIDX045WJ989BIACT
SODIUM HYDROXIDE55X04QC32IIACT
BORIC ACIDR57ZHV85D4IACT

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
14bb124a-ec7e-d6ae-e063-6294a90a466214bb1e99-7aa1-b0b7-e063-6394a90a24432024-03-28WarningsExact identifier
spl id: 14bb124a-ec7e-d6ae-e063-6294a90a4662
spl set id: 14bb1e99-7aa1-b0b7-e063-6394a90a2443

Reported adverse events (FAERS/openFDA)#

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