EXT Extreme Hair Therapy

Do not use if

• you are a woman
• your amount of hair loss is different than that shown on the side of this carton, or your hair loss is on the front of the scalp. Minoxidil Topical Solution 5% 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, infected, irritated or painful
• you use other medications 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 waler.
• 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
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months

Directions

• apply one mL 2 times a day directly onto the scalp in the area of hairloss
• using more or more often will not improve results
• continued use is necessary 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 booklet
• keep this 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 Minoxidil Topical Solution 5%
• in clinical studies with mostly while men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solution 2%
• store at room temperature between 20⁰ to 25⁰ C (68⁰ to 77⁰ F).

Inactive Ingredient

Questions and Comments?

Customer Information

• Provides more hair regrowth than Minoxidil 1%
• It takes time to regrow hair. Results may occur at  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.

• Women should not use minoxidil topical solution 5% because studies have shown it works no better in women than minoxidil topical solution 2%. Some women may also grow facial hair. In addition, minoxidil topical solution 5% may be harmful if used during pregnancy or  breastfeeding.
• Minoxidil topical solution 5% should not be used on babies or for children under 18 years old.
• Minoxidil topical solution 5% will not prevent or improve hair loss which may occur with the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; too much vitamin A intake), low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, minoxidil topical solution 5% will not improve hair loss due to:

•     damage from the use of hair care products which cause scarring or deep burns of the scalp.
•     hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.

EXT Extreme Hair Therapy Minoxidil SOLUTION Product Information Product Type Human otc drug label Item Code (Source) NDC:52512-601 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength minoxidil MINOXIDIL 50 mg Inactive Ingredients Ingredient Name Strength water propylene glycol ALCOHOL TERT-BUTYL ALCOHOL denatonium benzoate Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 60 in 1 BOTTLE 2 NDC:52512-601-60 88 in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 2004-08-26