FDA.reportPublic FDA data

Melissa

Manufacturer
Uriel Pharmacy Inc. | Uriel Pharmacy, Inc.
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:25

Label at a glance#

ProductMelissa
Active ingredientTOXICODENDRON PUBESCENS LEAF, MELISSA OFFICINALIS, ACONITUM NAPELLUS, ATROPA BELLADONNA
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: 100 gm contains: 35 gm Melissa (Lemon balm) 1X; Aconitum (Monkshood) 30X, Atropa belladonna (Nightshade) 30X, Rhus (Sumac) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spring water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Tea tree oil, Frankincense oil, Grapefruit seed extract, Myrrh oil

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of cold sores.

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 or if conditions worsen or persist. 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

Melissa CreamMelissa Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7203-1Melissa10 g in 1 TUBECREAM103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7203MELISSA CREAM [URIEL PHARMACY INC.]31 package rows20241210_1172ddf3-2aaf-6819-e063-6394a90ae382.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-720348951-7203-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MYRRH OILH74221J5J4IACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
MELISSA OFFICINALISYF70189L0NACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAVENDER OILZBP1YXW0H8IACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
SORBIC ACIDX045WJ989BIACT
TEA TREE OILVIF565UC2GIACT
CITRUS PARADISI SEED12F08874Y7IACT
FRANKINCENSE OIL67ZYA5T02KIACT
CETYL ALCOHOL936JST6JCNIACT

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
28dab798-8cd6-cf27-e063-6394a90af1471172ddf3-2aaf-6819-e063-6394a90ae3822024-12-09WarningsExact identifier
spl id: 28dab798-8cd6-cf27-e063-6394a90af147
spl set id: 1172ddf3-2aaf-6819-e063-6394a90ae382

Reported adverse events (FAERS/openFDA)#

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