LE PHOQUA HAIR REGROWTH SERUM BIOTIN 5% MINOXIDIL- hair regrowth serum liquid 
Stellans Inc.

----------

83565-008 Completed

Active Ingredient

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

Purpose

Hair Regrowth Treatment

Use

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

Warnings

·For external use only.
·Flammable: Keep away from fire or flame.

Do not use

·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

·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

Do not place this product within the reach of children

Directions

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

*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

Alcohol

Propylene Glycol

Purified Water

Questions

CONTACT US
www.lephoqua.com
info@lephoqua.com

PRINCIPAL DISPLAY PANEL

1

LE PHOQUA HAIR REGROWTH SERUM BIOTIN 5% MINOXIDIL 
hair regrowth serum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83565-008-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)11/24/202309/09/2024
Labeler - Stellans Inc. (111157321)
Establishment
NameAddressID/FEIBusiness Operations
Stellans Inc.111157321label(83565-008) , manufacture(83565-008)

Revised: 9/2024
 
Stellans Inc.