MedPath

iBeaLee 5% Minoxidil Hair Regrowth Solution

Approved
Approval ID

40001edd-d98c-4e2a-e063-6394a90a9911

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Shenzhen Earth Surface Trading Co., Ltd.

DUNS: 454290055

Products 1

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

MINOXIDIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85636-002
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
MINOXIDIL
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (10)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
MINOXIDILActive
Quantity: 5 g in 100 mL
Code: 5965120SH1
Classification: ACTIB
CYMBOPOGON CITRATUS LEAFInactive
Code: 06JMS448M5
Classification: IACT
ROSEMARYActive
Quantity: 0.2 g in 100 mL
Code: IJ67X351P9
Classification: ACTIB
BIOTINActive
Quantity: 0.2 g in 100 mL
Code: 6SO6U10H04
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Use

Use to regrow hair of the scalp and beard growth for men and wemen

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

ACTIVE INGREDIENT

Minoxidil 5% w/w
Biotin 0.2% w/w
Rosemary 0.2% w/w

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

Hair Regrowth

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

Warnings
For external use only.
Keep out of reach of children.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

Do not use if

Do not use if
You have no family history of hair loss.
Your hair loss is sudden and/or patchy.
Your hair loss is associated with childbirth.
You do not know the reason for your hair loss.
You are under 18 years of age. Do not use on babies and children.
Your scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

When Using

When Using
Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/30/2025

Stop Use And Ask A Doctor

Stop Use And Ask A Doctor
Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
Scalp irritation or redness occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/11/2024

Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

DESCRIPTION SECTION

LOINC: 34089-3Updated: 9/30/2025

Directions

Directions
Apply twice a day. Once in the morning and another time in the
evening before bed
Spray directly on top of the scalp in the area to be treated
Using more than directed or more often will not improve results
Continued use is necessary to lncrease and then malntain your
hair regrowth

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/30/2025

Other information

Other information
Before use, read all information on carton and enclosed leaflet.
Store at controlled room temperature 10° to 30°C (50° to 80°F).
Do not incinerate container. Do not expose to heat or store at temperature above 104°F (40°C).

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive ingredients

Water, Propylene Glycol, Potassium Sorbate, Castor Oil, Lavender Oil, Cymbopogon Citratus Leaf, Chamomile

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/11/2024

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 10/11/2024

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iBeaLee 5% Minoxidil Hair Regrowth Solution - FDA Drug Approval Details