FDA Label for Follicle Follixil 5% Minoxidil Hair Regrowth-lotion
View Indications, Usage & Precautions
Follicle Follixil 5% Minoxidil Hair Regrowth-lotion Product Label
The following document was submitted to the FDA by the labeler of this product Guangzhou Ariel Biotech 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(S)
Minoxidil 5%
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
●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, iritated or painful.
●You use other medicines on the scalp.
Otc - 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 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.
Otc - Stop Use
●Chest pain, rapid heartbeat, faintness or dizziness occurs.
●Sudden, unexplained weight gain occurs.
●Your hands or feet swell.
●Scalp iritation or redness occurs.
●Unwanted facial hair growth occurs.
●You do not see hair regrowth in 4 months.
Otc - Keep Out Of Reach Of Children
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. (1-800-222-1222)
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.
●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Other Information
1.See hair loss pictures on side of this carton.
2.Before use, read all information on carton and enclosed leaflet.
3.Keep the carton. It contains important information.
4.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.
5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical
solution 5% for men provided more hair regrowth than minoxidil topical solution 2%，
6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.
Inactive Ingredients
Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide
Package Label - Principal Display Panel
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