LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL

Manufacturer
Stellans Inc.
Effective date
2023-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:45

Label at a glance#

ProductLE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL
Active ingredientMINOXIDIL
Label structure12 sections

Dosage and administration

1. Apply 1 ml with dropper2 times a day directly onto the scalp in the hair loss area. 2. Using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again. check grammar

Storage and handling

*Before use, read all information on carton and enclosed leaflet *Keep the carton. It contains important information. hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidill topical solution 5% for men *In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v............Hair Regrowth Treatment

Purpose

OTC - PURPOSE SECTION

Hair Regrowth Treatment

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

·For external use 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.
·Your scalp is red.

Stop Use

OTC - STOP USE SECTION

·Chest pain, rapid heartbeat, faintness , or dizziness occurs
sudden, unexplained weight gain occurs
·Your hands or feet swell scalp irritation or redness occurs
·Unwanted fa cial hair growth occurs
·You do not see hair regrowth in 4 months
·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.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not place this product within the reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

1. Apply 1 ml with dropper2 times a day directly onto the scalp in the hair loss area.

2. Using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
check grammar

Other information

STORAGE AND HANDLING SECTION

*Before use, read all information on carton and
enclosed leaflet
*Keep the carton. It contains important information.
hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidill topical solution 5% for men
*In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
*Store at 20°to 25℃(68°to 77°F). Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol

Propylene Glycol

Purified Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83565-007-012024-01-30C16284748780-11030e365-5ec8-111a-e063-dadaa90a10e20af4a607-206d-de30-e063-6394a90acd99

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83565-007-01LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83565-007LE PHOQUA HAIR REGROWTH SERUM BIOTIN 5% MINOXIDIL (HAIR REGROWTH SERUM) LIQUID [STELLANS INC.]11 package rows20231128_0af4a607-206d-de30-e063-6394a90acd99.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83565-00783565-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
0af4a607-206e-de30-e063-6394a90acd990af4a607-206d-de30-e063-6394a90acd992023-11-25WarningsExact identifier
spl id: 0af4a607-206e-de30-e063-6394a90acd99
spl set id: 0af4a607-206d-de30-e063-6394a90acd99

Reported adverse events (FAERS/openFDA)#

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