5% Minoxidil Hair Growth Foam with Biotin

Manufacturer
Jinan Guyun Technology Co., Ltd
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:31:52

Label at a glance#

Product5% Minoxidil Hair Growth Foam with Biotin
Active ingredientMINOXIDIL, BIOTIN
Label structure13 sections

Storage and handling

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Growth Foam with Biotin

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%
Biotin 0.5%

OTC - PURPOSE SECTION

Hair regrowth treatment for men and women

INDICATIONS & USAGE SECTION

Use to regrow hair of the scalp

WARNINGS SECTION

Flammable: keep away from fire or flame.

Keep out of reach of children.

For external use only

OTC - DO NOT USE SECTION

Your hair loss is sudden and/or patchy.
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

Do not apply on other parts of the body.

Avoid contact with the eyes. In case of accidental contact, rinse eyes with largeamounts 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 2 months with twice a davusage, for some people, you may need to use this product for at least 4months before you see results.
The amount of hair regrowth is different for each person. This product willnot work for all people.

OTC - STOP USE SECTION

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden,unexplained weight gain occurs.
Your hands or feet swell.
Scalp irritation or redness occurs.
Unwanted facial hair growth occurs,
You do not see hair regrowth in 4 months,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Apply half a capful 2 times a day to the scalp in the hair loss area.

Massage into scalp with fingers, then wash hands well.

See enclosed leaflet for complete directions on how to use.

Using more or more often will not improve results.

Continued use is necessary to increase and keep your hair regrowth or hairloss will begin again.

STORAGE AND HANDLING SECTION

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)

INACTIVE INGREDIENT SECTION

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
EDETATE DISODIUM
ISOBUTANE
BUTANE
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel2label2label6label6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83988-002-015% Minoxidil Hair Growth Foam with Biotin2 in 1 PACKAGEAEROSOL, FOAM21
83988-002-015% Minoxidil Hair Growth Foam with Biotin60 g in 1 BOTTLEAEROSOL, FOAM601
83988-002-025% Minoxidil Hair Growth Foam with Biotin60 g in 1 BOTTLEAEROSOL, FOAM601
83988-002-025% Minoxidil Hair Growth Foam with Biotin4 in 1 PACKAGEAEROSOL, FOAM41
83988-002-035% Minoxidil Hair Growth Foam with Biotin6 in 1 PACKAGEAEROSOL, FOAM61
83988-002-035% Minoxidil Hair Growth Foam with Biotin60 g in 1 BOTTLEAEROSOL, FOAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83988-0025% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN (MINOXIDIL) AEROSOL, FOAM [JINAN GUYUN TECHNOLOGY CO., LTD]16 package rows20241101_25afb31d-ac2d-758f-e063-6294a90ae686.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83988-00283988-002-01, 83988-002-02, 83988-002-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25afb31d-ac2e-758f-e063-6294a90ae68625afb31d-ac2d-758f-e063-6294a90ae6862024-10-30WarningsExact identifier
spl id: 25afb31d-ac2e-758f-e063-6294a90ae686
spl set id: 25afb31d-ac2d-758f-e063-6294a90ae686

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.