FDA.reportPublic FDA data

Hair Regrowth

Manufacturer
Guangzhou Ariel Biotech Co., Ltd.
Effective date
2024-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:09

Label at a glance#

ProductHair Regrowth
Active ingredientBIOTIN, MINOXIDIL SULFATE
Label structure12 sections

Dosage and administration

Directions: Shake the bottle well, hold it about 6 inches away from your scalp, and spray evenly over the desired areas. Massage gently to help absorption.

Storage and handling

No Data

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Minoxidil Sulfate. 3%

BIOTIN 1%

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment
Anti-hair loss

Use

INDICATIONS & USAGE SECTION

Use: To regrow hair of scalp and beard

Warnings

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep out of reach of children.If you are pregnant, nursing, or have any underlying medical condition,
consult your healthcare provider before using the product.

Do not use

OTC - DO NOT USE SECTION

Do not use: on broken or irritated scalp.

OTC - WHEN USING SECTION

When Using Section: When using this product, avoid contact with eyes. If contact occurs, rinse
thoroughly with water. Discontinue use if any irritation or adverse reaction occurs.

OTC - STOP USE SECTION

●Chest pain, rapid heartbeat, faintness or dizziness occurs.
●Scalp iritation or redness occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Shake the bottle well, hold it about 6 inches away from your scalp, and spray evenly over
the desired areas. Massage gently to help absorption.

Other information

STORAGE AND HANDLING SECTION

No Data

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Aroma, Caffeine, Ethylhexylglycerin, Hyaluronic Acid, Peg-40 Hydrogenated Castor Oil,
Phenoxyethanol, Propylene Glycol, Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
84148-007-01Hair Regrowth60 mL in 1 BOTTLESPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84148-007HAIR REGROWTH SPRAY [GUANGZHOU ARIEL BIOTECH CO., LTD.]11 package rows20240730_1d911cde-73da-934c-e063-6394a90a7cac.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84148-00784148-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AROMADENDRIN7YA4640575IACT
CAFFEINE3G6A5W338EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYALURONIC ACIDS270N0TRQYIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BIOTIN6SO6U10H04ACTIB
WATER059QF0KO0RIACT
MINOXIDIL SULFATEHM46T3593QACTIB

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
1d9111a3-a380-9350-e063-6394a90a54cd1d911cde-73da-934c-e063-6394a90a7cac2024-07-18WarningsExact identifier
spl id: 1d9111a3-a380-9350-e063-6394a90a54cd
spl set id: 1d911cde-73da-934c-e063-6394a90a7cac

Reported adverse events (FAERS/openFDA)#

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