85038-003 5% Minoxidil Hair Regrowth Foam

Manufacturer
Lianjiang Shanlilai E-commerce Co., Ltd.
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:27

Label at a glance#

Product5% Minoxidil Hair Regrowth Foam
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°C (68° to 77°F). Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Regrowth Foam

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%
Biotin 0.5%

OTC - PURPOSE SECTION

Hair regrowth treatment

INDICATIONS & USAGE SECTION

Use to regrow hair on the top of the scalp

WARNINGS SECTION

For external use only. For use by men only.
Extremely Flammable:Avoid fire, flame, or smoking during andimmediately following application.

OTC - DO NOT USE SECTION

you are a woman.
your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.
You have no family history of hair loss.
Your hair loss is sudden andjor 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.
You use other medicines on the scalp.
Your scalp is red, inflamed, infected, irritated, or painful.

OTC - WHEN USING SECTION

Do not apply on other parts of the body.
Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.
Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.
The amount of hair regrowth is different for each person.This product will not work for all men.

OTC - STOP USE SECTION

if chest pain, rapid heartbeat, faintness, or dizziness occurs.
if sudden, unexplained weight gain occurs.
if your hands or feet swell.
if scalp irritation or redness occurs.
if unwanted facial hair growth occurs.
if you do not see hair regrowth in 6 months.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.

DOSAGE & ADMINISTRATION SECTION

See enclosed leaflet for complete directions on how to use.
Apply half a capful twice daily directly to the scalp in the hair lossarea.
Massage into scalp with fingers, then wash hands well.
Using more or more often will not improve results.
Continued use is necessary to increase and keep your hair regrowthor hair loss 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°C (68° to 77°F).

Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

INACTIVE INGREDIENT SECTION

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-003-015% Minoxidil Hair Regrowth Foam1 in 1 PACKAGEAEROSOL, FOAM12
85038-003-015% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602
85038-003-025% Minoxidil Hair Regrowth Foam2 in 1 PACKAGEAEROSOL, FOAM22
85038-003-025% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602
85038-003-035% Minoxidil Hair Regrowth Foam3 in 1 PACKAGEAEROSOL, FOAM32
85038-003-035% Minoxidil Hair Regrowth Foam60 g in 1 BOTTLEAEROSOL, FOAM602

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85038-00385038-003-01, 85038-003-02, 85038-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
4e77ed4b-0818-3613-e063-6394a90a2b5428fc8b76-ec7f-f4be-e063-6394a90a11f72026-04-02WarningsExact identifier
spl id: 4e77ed4b-0818-3613-e063-6394a90a2b54
spl set id: 28fc8b76-ec7f-f4be-e063-6394a90a11f7

Reported adverse events (FAERS/openFDA)#

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