FDA.reportPublic FDA data

5% Minoxidil with Biotin

Manufacturer
Guangzhou Borderless Technology Co., Ltd.
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:56

Label at a glance#

Product5% Minoxidil with Biotin
Active ingredientBIOTIN, MINOXIDIL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5%
Biotin 0.2%

OTC - PURPOSE SECTION

Hair Regrowth

INDICATIONS & USAGE SECTION

Use to regrow hair of the scalp and beard growth for men

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

You have no family history of hair loss
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

Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.

OTC - STOP USE SECTION

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
Scalp irritation or redness occurs.
Keep out of reach of children.
lf swallowed, get medical help or contact a Poison Control Center(1-800-222-1222)right away

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 3-6 drops Minoxidil Serum directly onto scalp on the hair lossarea.
Use fingertips to massage solution into skin/hair for 1 minutes thenwash hands thoroughlye.
Used once daily on clean dry hair for best results.

INACTIVE INGREDIENT SECTION

Butylene Glycol
Glycerin
Alcohol
Panthenol
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionPSN1
2707693biotin 2 MG/ML / minoxidil 50 MG/ML Topical SolutionSCD1
2707693biotin 0.2 % / minoxidil 5 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85304-001-025% Minoxidil with Biotin2 in 1 BOXSOLUTION21
85304-001-025% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-045% Minoxidil with Biotin4 in 1 BOXSOLUTION41
85304-001-045% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-065% Minoxidil with Biotin60 mL in 1 BOTTLESOLUTION601
85304-001-065% Minoxidil with Biotin6 in 1 BOXSOLUTION61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85304-0015% MINOXIDIL WITH BIOTIN (MINOXIDIL) SOLUTION [GUANGZHOU BORDERLESS TECHNOLOGY CO., LTD.]1Current NDC, 6 package rows20250312_300bc4e7-e795-4f32-e063-6394a90a1e67.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85304-00185304-001-02, 85304-001-04, 85304-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIOTIN6SO6U10H04ACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
ALCOHOL3K9958V90MIACT

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
5% Minoxidil with BiotinMINOXIDILGuangzhou Borderless Technology Co., Ltd.300bc4e7-e795-4f32-e063-6394a90a1e672025-03-11WarningsExact identifier
ndc (package): 85304-001-06
ndc (package): 85304-001-02
ndc (package): 85304-001-04
ndc (product): 85304-001
ndc11 (package): 85304000106
ndc11 (package): 85304000104
ndc11 (package): 85304000102
spl id: 300bc4e7-e796-4f32-e063-6394a90a1e67
spl set id: 300bc4e7-e795-4f32-e063-6394a90a1e67