FDA Label for Gainextra Hair Regrowth Treatment For Men 5%
View Indications, Usage & Precautions
Gainextra Hair Regrowth Treatment For Men 5% Product Label
The following document was submitted to the FDA by the labeler of this product Gabar Health Sciences Corp.. 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.
Otc - Active Ingredient
Minoxidil 5% w/v
Otc - Purpose
Hair regrowth treatment for men
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
Otc - Do Not Use
Do not use if
■ you are a woman
■ your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp. 5% minoxidil topical solution 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
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
Otc - When Using
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 everyone.
Otc - 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
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ Prim the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
■ apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss
■ 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 Safety Information
■ see hair loss pictures on side of this carton
■ before use, read all information on carton and enclosed leaflet
■ keep this 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 5% minoxidil topical solution for men
■ in clinical studies of mostly white men aged 18-19 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
■ store at controlled room temperature between 68°-77°F (20°-25°C).
Inactive Ingredient
alcohol, propylene glycol, purified water
Package Label.Principal Display Panel
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