MINOXIDIL- minoxidil solution
Akorn
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Drug Facts
Warnings
For external use only
Flammable: Keep away from fire or flame
Do no use if
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- your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
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- you have no family history of hair loss
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- your hair loss is sudden and/or patchy
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- you do not know the reason for your hair loss
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- you are under 18 years of age. Do not use on babies and children.
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- your scalp is red, inflamed, infected, irritated, or painful
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- you use other medicines on the scalp
When using this product
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- do not apply on other parts of the body
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- avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
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- some people have experienced changes in hair color and/or texture
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- it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results.
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- the amount of hair regrowth is different for each person. This product will not work for everyone.
Stop use and ask a doctor if
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- chest pain, rapid heartbeat, faintness, or dizziness occurs
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- sudden, unexplained weight gain occurs
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- your hands or feet swell
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- scalp irritation or redness occurs
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- unwanted facial hair growth occurs
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- you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding.
Directions
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- apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
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- using more or more often will not improve results
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- continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Other Information
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- see hair loss pictures on side of this carton
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- before use, read all information on carton and enclosed insert
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- keep the carton. It contains important information.
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- 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 reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
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- store at controlled room temperature 20° to 25°C (68° to 77°F)
| MINOXIDIL
minoxidil solution |
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| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-001) | |
Revised: 5/2022
Document Id: 6361c40e-40a1-4c1b-a89f-a39771e094d9
Set id: 15caf429-1ce2-4306-9cff-54d04335ebb3
Version: 5
Effective Time: 20220531
Akorn