MedPath

5% Minoxidil Hair Growth Sprays Serum

83766-106 5% Minoxidil Hair Growth Sprays Serum

Approved
Approval ID

360844c7-c5a0-9f13-e063-6294a90a66a6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Shenzhen Joyuflsh Technology Co.,Ltd.

DUNS: 603012375

Products 1

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

Minoxidil

PRODUCT DETAILS

NDC Product Code83766-106
Application Number505G(a)(3)
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
Generic NameMinoxidil

INGREDIENTS (8)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/26/2025

Use to regrow hair and beard.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Minoxidil 5%
Biotin 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

Hair Regrowth Treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/26/2025

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/26/2025

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: 5/26/2025

Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
Some people have experienced changes in hair color andlor texture.
lt takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, youmay need to use this product for at least 6 months before you see results. The amount of hair regrowth isdifferent 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: 5/26/2025

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
If 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: 5/26/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/26/2025

1.Make sure your hair and scalp are dry(no need to wash your hair before each use).
2.Apply 3-4 pumps of spray directly to the treated area of the scalp.
3.Gently massage into the scalp or thinning hair areas until absorbed.
4.Continued use is required to increase and maintain hair regrowth. Discontinuation may lead to hair loss.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/26/2025

Butylene Glycol
Glycerin
Alcohol
Castor oil
Dexpanthenol
Water

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5% Minoxidil Hair Growth Sprays Serum - FDA Approval | MedPath