FDA Label for Hair Regen Minoxidil 5% Hair Growth Treatment
View Indications, Usage & Precautions
Hair Regen Minoxidil 5% Hair Growth Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Guangzhou Hanhai Trading Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Minoxidil 5% w/ v.
Purpose
Hair regrowth treatment for people
Use
to regrow hair on the top of the scalp
Warnings
For external use only. For use men only.
Flammable: Keep away from fire or flame
Do Not Use
■You are a woman
■Your amount of hairloss is different than that shown on
the side of this carton ar your hairloss is on the front of
the scalp Minoxidil topical solution 5% is notintended
for frontal baldness or receding hairdine.
■ 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
When Using
■ 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 people, 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 people.
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 facial hair growth occurs.
·You do not see hair regrowth in 4 months.
Ask Doctor
If have heart disease.
Keep Oot Of Reach Of Children
Yes Keep Out Of Reach Of Children
Directions
■ apply one ml with fropper 2times 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
For best results: Keep using (Men use twice a daily. Women use once a day).
Other Information
■ see hair loss pictures on side of this carton
■ before use, read all information on carton
■ 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 Hair Regrowth Treatment for men and women
■ In clinical studies with mostly white men and women aged 18-49 years with
moderate degrees of hair loss, Hair Regrowth Treatment for people provided
more hair regrowth than minoxidil topical solution 2%
■ store at 20° to 25°C (68° to 77°F). Keep tightly closed.
Inactive Ingredients
alcohol, propylene glycol, purified water
Questions
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