FDA Label for Bosley Md Extra Strength For Men

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
OTC - PURPOSE
USE
WARNINGS
OTC - DO NOT USE
OTC - ASK DOCTOR
OTC - WHEN USING
OTC - STOP USE
DOSAGE & ADMINISTRATION
OTHER SAFETY INFORMATION
INACTIVE INGREDIENT
OTC - QUESTIONS
OTC - KEEP OUT OF REACH OF CHILDREN
OTC - PREGNANCY OR BREAST FEEDING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bosley Md Extra Strength For Men Product Label

The following document was submitted to the FDA by the labeler of this product Scientific Hair Research, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment for men

Use

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Otc - Do Not Use

Do not use if

■ You are a woman

■ Your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp. 5% Minoxidil Topical Solution 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 medicines on the scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

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 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.

Otc - Stop Use

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

Dosage & Administration

■ Apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss

■ 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 Safety Information

See hair loss pictures on side of this carton
Before use, read all information on carton and enclosed leaflet
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 5% minoxidil topical solution for men
In clinical studies of mostly white men aged 18-19 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 between 68° - 77°F (20°-25°C).

Inactive Ingredient

Alcohol, Propylene Glycol, Purified Water

Otc - Questions

Questions or comments? Call your helath professionals or BOSLEYMD at 1(800)BOSLEY1

Otc - Keep Out Of Reach Of Children