FDA Label for Rootly Extra Strength Hair Regrowth Treatment For Men

Otc - Active Ingredient

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment for men

Use

to regrow hair on the top of the scalp

Warnings

For external use only.

Flammable: Keep away from fire or flame.

Otc - Do Not Use

Do not use if

• You are a woman
• Your degree of hair loss is different than that shown on 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 or children.
• Your scalp is red, inflammed, infected, irritated, or painful
• You use other medicines on your scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - When Using

When using this product

• Do not apply on other parts of the body
• Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• Some people have experienced change in hair color and/or texture. It takes time to regrow hair. For some men, you may need to use this product 2 times a day 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.

Otc - Stop Use

Stop use and ask 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

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

Otc - 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

• 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 men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

• store at controlled room temperature 68° to 77°F (20° to 25°C).

Inactive Ingredient

lcohol, Propylene Glycol, Purified Water

Otc - Questions

Questions or comments

Call toll-free 1-800-681-0241 or visit hellorootly.com