Follicle Follixil 5% Minoxidil Hair Regrowth-Lotion

Manufacturer
Guangzhou Ariel Biotech Co., Ltd.
Effective date
2024-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:17

Label at a glance#

ProductFollicle Follixil 5% Minoxidil Hair Regrowth-Lotion
Active ingredientMINOXIDIL
Label structure12 sections

Dosage and administration

●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area. ●Using more or more often will not improve results. ●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Storage and handling

1.See hair loss pictures on side of this carton. 2.Before use, read all information on carton and enclosed leaflet. 3.Keep the carton. It contains important information. 4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men. 5.In clinical studies with mostly white men aged between 18-49 years with moderate degre...

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men.

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton.

Warnings

WARNINGS SECTION

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

●You are a woman.
●Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the
scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
●You have no family history of hair loss.
●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, iritated 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 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 2 months with twice a day usage. For some men, you may need to
use this product for at least 4 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

●Chest pain, rapid heartbeat, faintness or dizziness occurs.
●Sudden, unexplained weight gain occurs.
●Your hands or feet swell.
●Scalp iritation 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

May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
●Using more or more often will not improve results.
●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Other information

STORAGE AND HANDLING SECTION

1.See hair loss pictures on side of this carton.
2.Before use, read all information on carton and enclosed leaflet.
3.Keep the carton. It contains important information.
4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil
topical solution 5% for men.
5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical
solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,
6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN1
311724minoxidil 50 MG/ML Topical SolutionSCD1
311724minoxidil 3 GM per 60 ML Topical SolutionSY1
311724minoxidil 5 % Topical SolutionSY1
311724minoxidil 5 GM per 100 ML Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84148-005-01Follicle Follixil 5% Minoxidil Hair Regrowth-Lotion60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84148-005FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION LIQUID [GUANGZHOU ARIEL BIOTECH CO., LTD.]11 package rows20240423_16454f24-8333-4b6f-e063-6294a90a1c49.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84148-00584148-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
16454376-ea17-33d0-e063-6294a90a0a6216454f24-8333-4b6f-e063-6294a90a1c492024-04-17WarningsExact identifier
spl id: 16454376-ea17-33d0-e063-6294a90a0a62
spl set id: 16454f24-8333-4b6f-e063-6294a90a1c49

Reported adverse events (FAERS/openFDA)#

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