FDA.reportPublic FDA data

Polygonatum Cepa

Manufacturer
Uriel Pharmacy Inc.
Effective date
2019-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:31

Label at a glance#

ProductPolygonatum Cepa
Active ingredientONION, ECHINACEA ANGUSTIFOLIA, HIRUDIN, POLYGONATUM CYRTONEMA ROOT, VESPA CRABRO, GOLD, BOS TAURUS CARTILAGE, COPPER, SUS SCROFA SKIN, BOS TAURUS PLACENTA, SILICON DIOXIDE, THUJA OCCIDENTALIS WHOLE, SILVER, BARIUM CITRATE, GRAPHITE
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: Allium cepa (Onion) 2X, Echinacea (Purple coneflower) 2X, Hirudo (Leech) 4X, Polygonatum (Solomon’s seal) 4X, Vespa crabro (Hornet) 6X, Aurum met. (Metallic gold) 8X, Cartilago articularis (Bovine cartilage) 8X, Cuprum met. (Copper) 8X, Cutis (feti) (Porcine skin) 8X, Placenta (bovis) (Bovine placenta) 8X, Quartz (Rock crystal) 8X, Thuja (American arborvitae) 8X, Mesenchyme (Porcine embryonic connective tissue) 10X, Argentum met. (Silver) 12X, Barium citricum (Barium citrate) 12X, Graphites (Foliated crystalline carbon) 17X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Glycerin, Sodium alginate, Rosemary oil, Tea tree oil, Sorbic acid, Grapefruit seed extract

OTC - PURPOSE SECTION

Uses: Promotes skin regeneration and minimizes scars.

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
www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polygonatum Cepa GelPolygonatum Cepa Gel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-8358-52025-01-30C16284748780-12cef2736-b14b-d83d-e063-dadaa90ab31fPolygonatum Cepa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8358-5Polygonatum Cepa60 g in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8358POLYGONATUM CEPA GEL [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20191016_94f50c6d-2f31-7fd4-e053-2a95a90abadc.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-835848951-8358-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
SORBIC ACIDX045WJ989BIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
ROSEMARY OIL8LGU7VM393IACT
CITRUS PARADISI SEED12F08874Y7IACT
ONION492225Q21HACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
HIRUDINMNY7X23SRZACTIB
POLYGONATUM CYRTONEMA ROOTW93B56AH6RACTIB
VESPA CRABROK3ALM8S49HACTIB
GOLD79Y1949PYOACTIB
BOS TAURUS CARTILAGEUE77B10IIYACTIB
COPPER789U1901C5ACTIB
SUS SCROFA SKIN3EM4VW6TQNACTIB
BOS TAURUS PLACENTA83AL37E3A7ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
THUJA OCCIDENTALIS WHOLE5HBV6WCE3NACTIB
SILVER3M4G523W1GACTIB
BARIUM CITRATEJ9X0Y34WC2ACTIB
GRAPHITE4QQN74LH4OACTIB

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
94f50c6d-2f32-7fd4-e053-2a95a90abadc94f50c6d-2f31-7fd4-e053-2a95a90abadc2019-02-28WarningsExact identifier
spl id: 94f50c6d-2f32-7fd4-e053-2a95a90abadc
spl set id: 94f50c6d-2f31-7fd4-e053-2a95a90abadc

Reported adverse events (FAERS/openFDA)#

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