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Koi Beauty 5% Minoxidil Hair Growth Serum

Koi Beauty 5% Minoxidil Hair Growth Serum

Approved
Approval ID

358dfbcd-6152-2842-e063-6394a90a2ab4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Beijing Sea Heart International Science And Technology Co.,Ltd.

DUNS: 550747561

Products 1

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

5% Minoxidil Hair Growth Serum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85709-001
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
5% Minoxidil Hair Growth Serum
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (8)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NIACINAMIDEActive
Quantity: 0.2 mg in 100 mL
Code: 25X51I8RD4
Classification: ACTIB
MINOXIDILActive
Quantity: 5 mg in 100 mL
Code: 5965120SH1
Classification: ACTIB
BIOTINActive
Quantity: 0.3 mg in 100 mL
Code: 6SO6U10H04
Classification: ACTIB
ANGELICA SINENSIS ROOTInactive
Code: B66F4574UG
Classification: IACT
PANAX GINSENG ROOTInactive
Code: CUQ3A77YXI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

Package Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

HOW TO USE

1. Apply 1ml (a few drops) directly in the target area

2. Massage with your fingers for 2-3 minutes

3. Wait a few minutes for full absorption

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

How to use:

1. Apply 1 ml (a few drops) directly to the target area

2. Massage with fingers for 2-3 minutes

3. Wait a few minutes for full absorption

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Water, Glycerin, Propylene glycol, Ginseng extract, Angelica sinensis root

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 5/20/2025

Keep away from heat and direct sunlight

Place in a dry, cool place

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/20/2025

Please read all the information on the package carefully before use and store the product at room temperature of 20-25℃ (68-77℉)

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

5% Minoxidil, 0.3% Biotin, 0.2% Niacinamide

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Hari Regrowth Treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

WARNINGS:

1.For external use only.

2.Keep out of reach of children.

3.Keep away from fire and flames.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/20/2025

DO NOT USE:

1. Do not use on broken or irritated scalp.

2. You use other medicines on your scalp at the same time.

3. If you have heart disease, consult your doctor before use.

4. Discontinue use if any irritation or adverse reaction occurs.

5. You are under 18 years old. Do not use on infants and children.

6. You have no family history of hair loss, and the hair loss is sudden and/or pathological.

7. If you are pregnant, nursing, or have any under lying medical condition, consult your doctor before using the product.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/25/2025

WHEN USING THIS PRODUCT:

1. Please do not apply to other parts of the body. Avoid contact with eyes. If contact occurs, wash thoroughly with water immediately.

2. It takes time for hair to regrow, you may need to use this product twice a day for at least 4 months to see results.

3. The amount of hair regrowth varies from person to person.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

STOP USE AND CONSULT A DOCTOR IF:

Symptoms such as chest pain, rapid heartbeat, dizziness or fainting, sudden unexplained weight gain, swelling of hands and feet, etc. occur during use.

CONSULT YOUR DOCTOR:

During pregnancy or breastfeeding

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Koi Beauty 5% Minoxidil Hair Growth Serum - FDA Drug Approval Details