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Women's Minoxidil Hair Regrowth System


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Minoxidil 2% w/v


Purpose

Hair regrowth treatment


Use

to regrow hair on the scalp (vertex only, see picture on side of carton)


Warnings


SPL UNCLASSIFIED SECTION

For external use only.


SPL UNCLASSIFIED SECTION

Flammable: Keep away from fire or flame


Do not use if

  • your amount of hair loss is different than that shown on the side of this carton, because this product may not work for 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, irritated or painful
  • you use other medicines on the scalp

OTC - ASK DOCTOR SECTION

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 women, 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 women.

Stop use and ask a doctor if

you do not see hair regrowth in 4 months

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

May be harmful if used when pregnant or breast-feeding.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 day directly onto 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 will begin again

Other information

  • see hair loss pictures on opposite side
  • before use, read all information on carton and enclosed leaflet
  • keep the insert. It contains important information.
  • 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 placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at USP controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water