PROFOLIX MINOXIDIL HAIR GROWTH SERUM

Manufacturer
Guangzhou Jianyuan Biological Technology.Co.,Ltd
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:47

Label at a glance#

ProductPROFOLIX MINOXIDIL HAIR GROWTH SERUM
Active ingredientMINOXIDIL
Label structure13 sections

Dosage and administration

Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions. Apply 2-3 drops to the treated scalp area. Massage in with fingers and wash hands thoroughly. More serum or frequent use won't enhance results. Consistent use is key for hair regrowth. Stopping may lead to hair loss. Results may take at least 4 months with daily use (recommended: men: Once daily, Women:...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair Regrowth Treatment For Scalp and beard Only

Use

INDICATIONS & USAGE SECTION

To Regrow hair, For Scalp and beard Only

Warnings

WARNINGS SECTION

Keep away from kids.
for external use only
Flammable: Keep away from fire or flame
If swallowed, seek medical help, or contact poison control.
Store at controlled room temperature 20 to 25 ° C (68 to 77 ° F)
Do not expose to heat or store at temperature above 49 ° C (120 ° F)
Avoid fire, flame, or smoking during and immediately following application.

Do not use

OTC - DO NOT USE SECTION

your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
No family history of hair loss
Sudden or patchy hair loss
Unknown cause of hair loss
Under 18 years old (Avoid use on babies and children).
Red, inflamed, infected, irritated, or painful scalp.
Use of other scalp medications
May be harmful if used when pregnant or breast - feeding.

When Using

OTC - WHEN USING SECTION

Apply only on the scalp or beard
Avoid contact with eyes (Rinse with cool water if contact occurs)

Stop Use

OTC - STOP USE SECTION

Experience chest pain, rapid heartbeat, faintness, or dizziness
Sudden, unexplained weight gain
Swelling of hands or feet
Scalp irritation or redness
Unwanted facial hair growth
No hair regrowth after 4 months

Ask Doctor

OTC - ASK DOCTOR SECTION

If have Allergy, plz check with doctor

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Oot Of Reach Of Children

Directions

DOSAGE & ADMINISTRATION SECTION

Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions.
Apply 2-3 drops to the treated scalp area.
Massage in with fingers and wash hands thoroughly.
More serum or frequent use won't enhance results.
Consistent use is key for hair regrowth. Stopping may lead to hair loss.
Results may take at least 4 months with daily use (recommended: men: Once daily, Women: Twice daily)
Effectiveness varies from person to person.

IMPORTANT

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

The hair growth cycle is around 6 months. Consistent use is crucial for effectiveness, and visible results may appear after 3-4 months. Keep up the treatment post-initial improvements to sustain progress; discontinuation may lead to withdrawal.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis, Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin, Vitamin H (Biotin), Collagen.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN3
311724minoxidil 50 MG/ML Topical SolutionSCD3
311724minoxidil 3 GM per 60 ML Topical SolutionSY3
311724minoxidil 5 % Topical SolutionSY3
311724minoxidil 5 GM per 100 ML Topical SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-009-01PROFOLIX MINOXIDIL HAIR GROWTH SERUM60 mL in 1 BOTTLELIQUID603
81653-009-02PROFOLIX MINOXIDIL HAIR GROWTH SERUM180 mL in 1 BOTTLELIQUID1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81653-009PROFOLIX MINOXIDIL HAIR GROWTH SERUM LIQUID [GUANGZHOU JIANYUAN BIOLOGICAL TECHNOLOGY.CO.,LTD]32 package rows20231129_0a03dd76-e8c6-3979-e063-6294a90ad103.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81653-00981653-009-01, 81653-009-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
0b313556-868c-ec8c-e063-6394a90ad0760a03dd76-e8c6-3979-e063-6294a90ad1032023-11-28WarningsExact identifier
spl id: 0b313556-868c-ec8c-e063-6394a90ad076
spl set id: 0a03dd76-e8c6-3979-e063-6294a90ad103

Reported adverse events (FAERS/openFDA)#

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