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

Description

Minoxidil 2% w/v

Purpose

Hair regrowth treatment 


Medication Information

Purpose

Hair regrowth treatment 

Description

Minoxidil 2% w/v

Use

to regrow hair on the scalp

Warnings

For external use only

Flammable:Keep away from fire or flame

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

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

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).

Package Labeling:

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

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

Use

to regrow hair on the scalp

Purpose

Hair regrowth treatment 

Warnings

For external use only

Flammable:Keep away from fire or flame

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

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

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).

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

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


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