Bosley Minoxidil Topical Solution (2%) For Women

Bosley Minoxidil Topical Solution (2%) For Women
SPL v1
SPL
SPL Set ID 4fe1602f-797a-4469-b82c-3ade8a9c7fec
Route
TOPICAL
Published
Effective Date 2024-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-02-26

Description

Minoxidil 2.0%w/v

Purpose

Hair regrowth treatment for women


Medication Information

Purpose

Hair regrowth treatment for women

Description

Minoxidil 2.0%w/v

Use

to regrow hair on the top of the scalp (vertex only, see picture on side of box)

Label

Warnings

For external use only.

Flammable:keep away from fire or flame

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply one ml. (6 sprays) 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 amount of hair loss is different than that shown on the side of this box 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 and children.
  • your scalp is red, inflamed, infected, irritated, or painful
  • you use other medications on the scalp
Active Ingredient

Minoxidil 2.0%w/v

Other Information
  • see hair loss pictures on side of this box
  • before use, read all information on carton and enclosed insert
  • keep carton, it contains important information 
  • in clinical studies with mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using woman's minoxidil topical solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F)
Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

Call us at 1-800-267-5391 or visit website at www.bosleymd.com

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 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 or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months 

May be harmful if used

Keep Out of Reach of Children.

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

When Pregnant Or Breastfeeding.

Ask A Doctor Before Use If You Have 

heart disease


Structured Label Content

Use

to regrow hair on the top of the scalp (vertex only, see picture on side of box)

Label

Purpose

Hair regrowth treatment for women

Warnings

For external use only.

Flammable:keep away from fire or flame

Directions
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply one ml. (6 sprays) 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 amount of hair loss is different than that shown on the side of this box 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 and children.
  • your scalp is red, inflamed, infected, irritated, or painful
  • you use other medications on the scalp
Active Ingredient

Minoxidil 2.0%w/v

Other Information (Other information)
  • see hair loss pictures on side of this box
  • before use, read all information on carton and enclosed insert
  • keep carton, it contains important information 
  • in clinical studies with mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using woman's minoxidil topical solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F)
Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or comments?)

Call us at 1-800-267-5391 or 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 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 or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months 

May be harmful if used

Keep Out of Reach of Children. (Keep out of reach of children.)

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

When Pregnant Or Breastfeeding. (when pregnant or breastfeeding.)

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

heart disease


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