MedPath

Melissa

Melissa

Approved
Approval ID

3eef31ef-39a3-3813-e063-6394a90a82af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Uriel Pharmacy, Inc

DUNS: 043471163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Melissa

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-7222
Product Classification
G
Generic Name
Melissa
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (13)

TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
MELISSA OFFICINALISActive
Quantity: 1 [hp_X] in 1 g
Code: YF70189L0N
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
ACONITUM NAPELLUSActive
Quantity: 30 [hp_X] in 1 g
Code: U0NQ8555JD
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
FRANKINCENSE OILInactive
Code: 67ZYA5T02K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 30 [hp_X] in 1 g
Code: 6IO182RP7A
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 30 [hp_X] in 1 g
Code: WQZ3G9PF0H
Classification: ACTIB
MYRRH OILInactive
Code: H74221J5J4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Melissa Gel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active Ingredients: 100 gm contains: 35 gm Melissa (Lemon balm) 1X; Aconitum (Monkshood) 30X, Atropa belladonna (Nightshade) 30X, Rhus (Sumac) 30X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive Ingredients: Spring water, Glycerin, Boric acid, Sodium alginate, Lavender oil, Sodium hydroxide, Tea tree oil, Frankincense oil, Myrrh oil

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Use: Temporary relief of cold sores.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/16/2025

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

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 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

LOINC: 53413-1Updated: 9/16/2025

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

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