Active Ingredient
Minoxidil, USP 5% w/v
Hair Regrowth Treatment Solution
FDA Label NDC 82269-607
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seiseidou America, Inc. for the product Hair Regrowth Treatment (NDC 82269-607). 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 if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
Do Not Use If
- 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. Do not use on babies and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
Ask A Doctor Before Use If You Have
heart disease
When Using This Product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- some people have experienced changes in hair color and/or texture
- it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
- the amount of hair regrowth is different for each person. This product will not work for all men.
Stop Use And Ask A Doctor If
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- sudden, unexplained weight gain occurs
- your hands or feet swell
- scalp irritation or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
- 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
Other Information
- see hair loss pictures on side of this carton
- 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 minoxidil topical solution 5% for men
- In clinical studies with mostly white men aged 18 to 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 controlled room temperature 20° to 25°C (68° to 77°F)
Inactive Ingredients
alcohol (30% v/v), propylene glycol (50% v/v), purified water
Principal Display Panel
FOR MEN
EXTRA STRENGTH
NOT FOR USE BY WOMEN
MINOXIDIL TOPICAL SOLUTION, USP 5%
Hair Regrowth Treatment
FOR BEST RESULTS APPLY DIRECTLY TO SCALP TWICE DAILY
FOR EXTERNAL USE ONLY
ONE MONTH SUPPLY - ONE 60 mL (2fl oz) BOTTLE
Distributed by Seiseidou America
10880 Wilshire Blvd., Suite 1101
Los Angeles, CA 90024
Package Label
FORTERO Hair Regrowth Treatment
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