FDA.reportPublic FDA data

Melissa

Manufacturer
Uriel Pharmacy Inc.
Effective date
2019-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:07:44

Label at a glance#

ProductMelissa
Active ingredientMELISSA OFFICINALIS
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: 88.2 gm Melissa (Lemon balm) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Glycerin, Sodium alginate, Lavender oil, Trolamine, Sorbic acid,Tea tree oil, Grapefruit seed extract

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Melissa GelMelissa GelMelissa Gel BagMelissa Gel Bag

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-718648951-7186-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBIC ACIDX045WJ989BIACT
TEA TREE OILVIF565UC2GIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
LAVENDER OILZBP1YXW0H8IACT
CITRUS PARADISI SEED12F08874Y7IACT
MELISSA OFFICINALISYF70189L0NACTIB

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
cf442eb3-e92a-c77c-e053-2995a90a338c94e2491f-dad5-e296-e053-2a95a90aafc62021-10-26WarningsExact identifier
spl set id: 94e2491f-dad5-e296-e053-2a95a90aafc6

Reported adverse events (FAERS/openFDA)#

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