LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL

Manufacturer
Stellans Inc.
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:11

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83565-00883565-008-01

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
21ad072f-7b75-394c-e063-6394a90af63f15bda8d5-8c3d-6ba5-e063-6394a90a82d92024-09-09WarningsExact identifier
spl set id: 15bda8d5-8c3d-6ba5-e063-6394a90a82d9

Reported adverse events (FAERS/openFDA)#

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