FDA Label for Follinique

Active Ingredients:

Minoxidil 2.0% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on 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 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, infected, irritated, or painful
• you use other medications on the scalp

Otc - Ask Doctor

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 waler.
• some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. You may need to use this product 2 times a day 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
• 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

If pregnant or breast feeding, ask a health professional before use.

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

• 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 side of this carton
• before use, read all information on carton and enclosed leaflet
• in clinical research in mostly white women age 18-45 years with mild to moderate degrees of hair loss, the following response to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using women's Minoxidil Topical Solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without Minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth)
• keep the carton. It contains important information.
• store at controlled room temperature 20⁰ to 25⁰C (68⁰ to 77⁰F).

Inactive Ingredients:

alcohol , propylene glycol, purified water.

Questions Or Comments?

877-279-9024

Visit website at www.follinique.com

Package Label.Principal Display Panel

NDC 70788-579-01

Follinique

Women's 2% Minoxidil Topical Solution USP

Hair Regrowth Treatment

Reactivates Hair Follicles to Stimulate Regrowth

Clinically Proven to Help Regrow Hair

Unscented Topical Solution

follinique - follinique