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5% Minoxidil Hair Growth Topical Solution

85304-018 5% Minoxidil Hair Growth Topical Solution

Approved
Approval ID

3e569e69-55b9-1d01-e063-6294a90a88ed

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Guangzhou Borderless Technology Co., Ltd.

DUNS: 452282332

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 Code85304-018
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
DEXPANTHENOLInactive
Code: 1O6C93RI7Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MINOXIDILActive
Quantity: 5 g in 100 mL
Code: 5965120SH1
Classification: ACTIB
BIOTINActive
Quantity: 0.5 g in 100 mL
Code: 6SO6U10H04
Classification: ACTIB
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

label

INDICATIONS & USAGE SECTION

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

Use to regrow hair and beard.

OTC - ACTIVE INGREDIENT SECTION

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

Minoxidil 5%
Biotin 0.5%

OTC - PURPOSE SECTION

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

Hair Regrowth Treatment

WARNINGS SECTION

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

Keep out of reach of children.

For external use only

OTC - DO NOT USE SECTION

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

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: 9/9/2025

Avold contact with the eves. in case of accidental contact, rinse eves with large amounts of cool tap water
Some people have experienced changes in hair color and/or texture.
It takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use this product for at least 6 months before you see results. The amount of hair regrowth is diferent for each person.
Avoid contact with eyes. in case of accidental contact, rinse eyes with a large amount of cool tap water.

OTC - STOP USE SECTION

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

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
lf unwanted facial hair growth occurs
lf you do not see hair regrowth in 6 months.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children. f swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)right away.

DOSAGE & ADMINISTRATION SECTION

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

1. After opening the cap, apply 1 ml by pressing and dotting onto the scalp area to be treated.
2. Gently massage the scalp or sparse hair area until fully absorbed.
3. Use twice daily.
4. Continuous use is necessary to increase and maintain har regrowth. Stopping use may lead to hair loss

INACTIVE INGREDIENT SECTION

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

Butylene Glycol
Glycerin
Alcohol
Castor oil
Dexpanthenol
Water

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