MedPath

Rosmarinus Lavandula

Rosmarinus Lavandula

Approved
Approval ID

c3cc9a0f-7501-a0a5-e053-2995a90a767a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 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.

Rosmarinus Lavandula

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-8436
Product Classification
G
Generic Name
Rosmarinus Lavandula
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (20)

SLOEActive
Quantity: 2 [hp_X] in 1 g
Code: 3MLB4858X7
Classification: ACTIB
URTICA URENSActive
Quantity: 5 [hp_X] in 1 g
Code: IHN2NQ5OF9
Classification: ACTIB
BEEFActive
Quantity: 8 [hp_X] in 1 g
Code: 4PIB2155QP
Classification: ACTIB
OSTREA EDULIS SHELLActive
Quantity: 8 [hp_X] in 1 g
Code: 49OY13BE7Z
Classification: ACTIB
SUS SCROFA SKINActive
Quantity: 8 [hp_X] in 1 g
Code: 3EM4VW6TQN
Classification: ACTIB
SUS SCROFA UMBILICAL CORDActive
Quantity: 8 [hp_X] in 1 g
Code: 118OYG6W3H
Classification: ACTIB
BOS TAURUS SOMATIC NERVEActive
Quantity: 8 [hp_X] in 1 g
Code: N1R7LRU866
Classification: ACTIB
TINActive
Quantity: 8 [hp_X] in 1 g
Code: 387GMG9FH5
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
ROSEMARY OILInactive
Code: 8LGU7VM393
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
SAGE OILInactive
Code: U27K0H1H2O
Classification: IACT
CITRUS PARADISI SEEDInactive
Code: 12F08874Y7
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BOS TAURUS PLACENTAActive
Quantity: 8 [hp_X] in 1 g
Code: 83AL37E3A7
Classification: ACTIB
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Rosmarinus Lavandula Gel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/2/2021

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/2/2021

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/2/2021

Active Ingredients: Prunus spinosa (Blackthorn) 2X, Urtica urens (Small nettle) 5X, Anus (Bovine anus) 8X, Conchae (Oyster shells) 8X,Cutis feti. fem. (Porcine Skin - fetal, female) 8X, Funiculus umbilicalis (Bovine umbilical cord) 8X, Pudendum femin. (Bovine female external genitals) 8X, Stannum met. (Metallic tin) 8X, Pars fetalis - placenta (Bovine fetal placenta) 8X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/2/2021

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

Prepared using rhythmical processes.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/2/2021

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 is broken or missing.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/2/2021

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/2/2021

Use: Temporary relief of anal itching.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/2/2021

KEEP OUT OF REACH OF CHILDREN.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.