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FDA Approval

Koi Beauty 5% Minoxidil Hair Growth Serum

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
May 20, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Nicotinamide(0.2 mg in 100 mL)
Minoxidil(5 mg in 100 mL)
Biotin(0.3 mg in 100 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

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

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

550747561

Products1

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

Koi Beauty 5% Minoxidil Hair Growth Serum

Product Details

NDC Product Code
85709-001
Application Number
M032
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 20, 2025
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Code: 25X51I8RD4Class: ACTIBQuantity: 0.2 mg in 100 mL
MinoxidilActive
Code: 5965120SH1Class: ACTIBQuantity: 5 mg in 100 mL
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 0.3 mg in 100 mL
ANGELICA SINENSIS ROOTInactive
Code: B66F4574UGClass: IACT
PANAX GINSENG ROOTInactive
Code: CUQ3A77YXIClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label


INDICATIONS & USAGE SECTION

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

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


WARNINGS SECTION

WARNINGS:

1.For external use only.

2.Keep out of reach of children.

3.Keep away from fire and flames.

PRECAUTIONS SECTION

Keep away from heat and direct sunlight

Place in a dry, cool place


OTC - ACTIVE INGREDIENT SECTION

5% Minoxidil, 0.3% Biotin, 0.2% Niacinamide

OTC - PURPOSE SECTION

Hari Regrowth Treatment

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

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

OTC - DO NOT USE SECTION

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 - STOP USE SECTION

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

OTC - WHEN USING SECTION

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.


OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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


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