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

LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL by

Drug Labeling and Warnings

LE PHOQUA Hair Regrowth Serum BIOTIN 5% MINOXIDIL by is a Otc medication manufactured, distributed, or labeled by Stellans Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LE PHOQUA HAIR REGROWTH SERUM BIOTIN 5% MINOXIDIL 
hair regrowth serum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83565-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83565-007-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	11/24/2023

Labeler - Stellans Inc. (111157321)

Establishment
Name	Address	ID/FEI	Business Operations
Stellans Inc.		111157321	label(83565-007) , manufacture(83565-007)