Active Ingredient
Minoxidil 5% w/v............Hair Regrowth Treatment
Le Phoqua Hair Regrowth Serum Biotin 5% Minoxidil
FDA Label NDC 83565-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Stellans Inc. for the product Le Phoqua Hair Regrowth Serum Biotin 5% Minoxidil (NDC 83565-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, stop use, keep oot of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
[email protected]
Principal Display Panel
1 (Label)
* Please review the disclaimer below.
