FDA Label for Growell Womens Hair Regrowth Treatment 2 Minoxidil
View Indications, Usage & Precautions
Growell Womens Hair Regrowth Treatment 2 Minoxidil Product Label
The following document was submitted to the FDA by the labeler of this product Apira Science, Inc.. 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 2% w/v
Purpose
Hair regrowth treatment
Use
to regrow hair on the top of the scalp
Warnings:
For external use only.
Flammable:Keep away from fire or flame
Do Not Use If:
- your degree of hair loss is different that than shown on the side of this carton because this product may not work on you
- you have no family history of hair loss
- your hair loss is sudden and/or patchy
- your hair loss is associated with childbirth
- 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 the 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. 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.
Stop Use And Ask A Doctor If
- chest pain, rapid heartbeat, faintness, or dizziness occurs
- scalp irritation or redness occurs
- sudden, unexplained weight gain occurs
- unwanted facial hair growth occurs
- your hands or feet swell
- you do not see hair regrowth in 4 months
Keep Out Of Reach Of Children.
If swallowed, get medical help, or contact a Poison Contrl Center right away.
Directions
- apply one mL with dropper 2 times a daydirectly on to 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 wil begin again
Other Information
- See hair loss pictures on side of this carton
- before use, reatd 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 5 % minoxidil topical solution for men
- in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: (19% of women reporting moderate hair regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- store at controlled room temperature 20° to 25°C (68° to 77°F).
Inactive Ingredients
Alcohol, Propylene Glycol, Purified Water
Questions Or Comments?
Call toll-free 1-(866)-982-7472
Visit our website at www.GroWellHair.com
Package Labeling:
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