FDA Label for Mens Rapid Reinvent 5 Minoxidil Solution
View Indications, Usage & Precautions
Mens Rapid Reinvent 5 Minoxidil Solution Product Label
The following document was submitted to the FDA by the labeler of this product The Self And Body Love Company Llc. 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.
Drug Facts
Active Ingredient
Minoxidil 5% w/v
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the scalp (vertex only, see picture 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 hairloss is different 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, 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
• unwated facial 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.
Directions
• apply one mL with dropper 2 times a daydirectly onto the scalp in the loss area • Using more or often will not improve results • Continued use is necessary or hair loss will begin again
Other Information
• see hari 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 trails with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degree of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20° to 25°C (68° TO 77°F).
Inactive Ingredients
Alcohol, Propylene Glycol, Purified Water
Questions Or Comments?
1(888) 888-9348 Visit us at www.rapidreinvent.com
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