bosley woman 2% minoxidil topical solution

bosley woman 2% minoxidil topical solution
SPL v2
SPL
SPL Set ID a70d0bd4-ac02-4a55-b9e7-c20dfe830f08
Route
topical
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
minoxidil (20 mg)
Inactive Ingredients
propylene glycol water alcohol

Identifiers & Packaging

Marketing Status
anda active Since 2023-11-03

Purpose

Hair regrowth treatment 

Description

Minoxidil 2% w/v


Medication Information

Warnings

For external use only

Flammable:Keep away from fire or flame

Purpose

Hair regrowth treatment 

Directions

apply one mL with dropper 2 times a daydirectly 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.

• 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 the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minomal regrowth). • store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Description

Minoxidil 2% w/v

Use

to regrow hair on the scalp

Drug Facts

Do Not Use If:

• your degree of hair loss is more than that shown on the side of this carton. Minoxidil topical solution 2% may not work. • 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 on and children • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp

Active Ingredient

Minoxidil 2% w/v

Package Labeling:

Questions Or Comments?

Call toll-free 1-800-BOSLEY1

  • Visit Website at www.bosleymd.com
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. 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 women.

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 of redness occurs

• unwanted facial hair growth occurs

• you do not see hair regrowth in 4 months

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

Keep Out of Reach of Children.

If swallowed, get medical help, or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have 

heart disease


Structured Label Content

Warnings

For external use only

Flammable:Keep away from fire or flame

Purpose

Hair regrowth treatment 

Directions

apply one mL with dropper 2 times a daydirectly 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 (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.

• 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 the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minomal regrowth). • store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

Use

to regrow hair on the scalp

Drug Facts

Do Not Use If: (Do not use if:)

• your degree of hair loss is more than that shown on the side of this carton. Minoxidil topical solution 2% may not work. • 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 on and children • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp

Active Ingredient

Minoxidil 2% w/v

Package Labeling:

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-BOSLEY1

  • Visit Website at www.bosleymd.com
When Using This Product (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. 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 women.

Stop Use and Ask A Doctor If (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 of redness occurs

• unwanted facial hair growth occurs

• you do not see hair regrowth in 4 months

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

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.

Ask A Doctor Before Use If You Have  (Ask a doctor before use if you have )

heart disease


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)