FDA.reportPublic FDA data

Berberis Prunus

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:21

Label at a glance#

ProductBerberis Prunus
Active ingredientBERBERIS VULGARIS ROOT BARK, LEMON, QUINCE, SLOE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Under age 2: Consult a doctor.

DOSAGE & ADMINISTRATION SECTION

Directions: Apply to skin in and around nose as needed.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 50 gm Prunus spinosa (Blackthorn) 1X; Berberis (Barberry) 1X, Citrus (Lemon) 2X, Cydonia (Quince) 2X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lanolin, Organic olive oil, Sunflower seed oil, Beeswax, Cajeput oil, Colloidal silica, Eucalyptus oil, Organic cane alcohol, Citric acid, Sorbic acid, Tea tree oil, Peruvian balsam, Grapefruit seed extract

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of nasal congestion.

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, 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 on bag 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

Berberis Prunus OintmentBerberis Prunus Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2148-5Berberis Prunus10 g in 1 TUBEOINTMENT102
48951-2148-5Berberis Prunus1 in 1 BAGOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2148BERBERIS PRUNUS OINTMENT [URIEL PHARMACY INC.]22 package rows20241208_0f52d1a8-1528-ec2d-e063-6394a90af624.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-214848951-2148-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
CAJUPUT OILJ3TO6BUQ37IACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SORBIC ACIDX045WJ989BIACT
BALSAM PERU8P5F881OCYIACT
CITRUS PARADISI SEED12F08874Y7IACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
LEMON24RS0A988OACTIB
QUINCE12MCS4H09NACTIB
SUNFLOWER OIL3W1JG795YIIACT
ALCOHOL3K9958V90MIACT
SLOE3MLB4858X7ACTIB

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
2888498a-c30f-3020-e063-6394a90a4ed70f52d1a8-1528-ec2d-e063-6394a90af6242024-12-05WarningsExact identifier
spl id: 2888498a-c30f-3020-e063-6394a90a4ed7
spl set id: 0f52d1a8-1528-ec2d-e063-6394a90af624

Reported adverse events (FAERS/openFDA)#

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